At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. Requirements To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combination of education and experience. Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures. Strong written and verbal communication skills including good command of English and local language. Representative, outgoing and client focused. Ability to work in a fast-paced challenging environment of a growing company. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Effective clinical monitoring skills (all kind of visits mastered). Ability to perform travel an average of 8 days on site per month, depending on project needs. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Excellent understanding of the drug development process. Ability to proactively identify and resolve issues in a timely manner. Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. Effective organizational and time management skills. Ability to manage multiple projects and strong attention to detail. Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. Ability to meet project requirements. Proven flexibility and adaptability. Ability to work in a team or independently and to effectively prioritize tasks. Disclaimers:*Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers:*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Biostatistician II to join our A-team (hybrid*). The Sr. Biostatistician II (Sr2Bios) supports the statistical analysis and clinical data activities of the Allucent Biostatistics/Statistical Programming team. This position leads projects, writes statistical documents and statistical sections of study documents for simple to moderately complex studies, and provides senior review of statistical documents and outputs. This position may assist in the programming of datasets and outputs using SAS®. The Sr2Bios will regularly interact with other members of the Allucent biostatistics project team and will interact with clients when leading a study. In this role your key tasks will include: Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial data Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderately complex studies Familiarity with complex statistical methods and concepts Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity Execute a statistical analysis of any complexity as specified in a protocol or analysis plan Interpret and communicate results for complex statistical analyses and outputs Develop and/or review the statistical sections of a study protocol for simple to moderately complex studies Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports Support responses to regulatory questions on statistical issues relating to client regulatory submissions Working knowledge of SAS® for production and validation of datasets and statistical outputs Write and review specifications for complex ADaM or analysis datasets Annotate or review annotations of TLF mocks to assist programming efforts. Working knowledge of CDISC standards Review CRF design to ensure it conforms with the study protocol and analysis needs. Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial dat Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderately complex studies. Familiarity with complex statistical methods and concepts Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity Execute a statistical analysis of any complexity as specified in a protocol or analysis plan Interpret and communicate results for complex statistical analyses and outputs Develop and/or review the statistical sections of a study protocol for simple to moderately complex studies Review data management documents as requested to ensure the integrity of study data Lead simple to moderately complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing Lead management of project budgets, the identification of out-of-scope work, and the change order process Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value. Actively support staff learning & development within the company Identify, recommend, and execute departmental initiatives, tools, and process solutions to enhance efficiency and quality. Review and evaluate biostatistics and statistical programming processes and procedures within the Quality Management System Represent Allucent at proposal bid defences and/or marketing meetings with prospective clients Establish positive relationships with current and future clients. Requirements To be successful you will possess: Bachelor's degree; master's degree preferred, in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare . Minimum 5 years of relevant work experience. Good knowledge of GxP. Familiarity with relevant regulations and guidelines. GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements. Working knowledge of computer systems, applications and operating systems. Demonstrate critical thinking and analytic skills Strong written and verbal communication skills including good command of the English language. Ability to work in a fast-paced challenging environment of a growing company. Strong individual initiative. Excellent attention to detail and commitment to quality. Proficiency with various computer applications such as Word, Excel, and PowerPoint. Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors. Knowledge of SAS. Collaborative and client-focused. Ability to effectively manage multiple tasks and projects. Strong leadership skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. Requirements To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combination of education and experience. Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures. Strong written and verbal communication skills including good command of English and local language. Representative, outgoing and client focused. Ability to work in a fast-paced challenging environment of a growing company. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Effective clinical monitoring skills (all kind of visits mastered). Ability to perform travel an average of 8 days on site per month, depending on project needs. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Excellent understanding of the drug development process. Ability to proactively identify and resolve issues in a timely manner. Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. Effective organizational and time management skills. Ability to manage multiple projects and strong attention to detail. Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. Ability to meet project requirements. Proven flexibility and adaptability. Ability to work in a team or independently and to effectively prioritize tasks. Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a highly skilled and experienced Application Developer to join our A-team (hybrid*). The ideal candidate will have a minimum of 2 years of experience in software development and possess a strong proficiency in both backend and frontend technologies. As an Application Developer, you will play a crucial role in designing, developing, and maintaining high-quality applications that meet the needs of our clients. In this role your key tasks will include: Design, develop, and maintain web applications using best practices and current technologies. Write clean, scalable, and efficient code in backend technologies such as JAVA, Node.JS, and .NET. Develop user-friendly interfaces using frontend frameworks like React and Angular. Collaborate with cross-functional teams to define, design, and ship new features. Implement and manage DevOps processes, including CI/CD pipelines, automated testing, and infrastructure as code. Participate in code reviews and contribute to a continuous improvement mindset. Stay updated with the latest industry trends and technologies to ensure our applications remain relevant and competitive. Provide technical support and troubleshooting for existing applications as needed. Requirements To be successful you should possess: Minimum of 2 years of professional experience in application development. Proficiency in backend technologies: JAVA, Node.JS, and .NET. Strong experience with frontend frameworks: React and Angular. Deep understanding of DevOps processes and best practices. Additional experience in Python is preferred. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Bachelor's degree in Computer Science, Information Technology, or a related field is preferred. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. Requirements To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combination of education and experience. Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures. Strong written and verbal communication skills including good command of English and local language. Representative, outgoing and client focused. Ability to work in a fast-paced challenging environment of a growing company. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Effective clinical monitoring skills (all kind of visits mastered). Ability to perform travel an average of 8 days on site per month, depending on project needs. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Excellent understanding of the drug development process. Ability to proactively identify and resolve issues in a timely manner. Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. Effective organizational and time management skills. Ability to manage multiple projects and strong attention to detail. Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. Ability to meet project requirements. Proven flexibility and adaptability. Ability to work in a team or independently and to effectively prioritize tasks. Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a highly skilled and experienced Application Developer to join our A-team (hybrid*). The ideal candidate will have a minimum of 2 years of experience in software development and possess a strong proficiency in both backend and frontend technologies. As an Application Developer, you will play a crucial role in designing, developing, and maintaining high-quality applications that meet the needs of our clients. In this role your key tasks will include: Design, develop, and maintain web applications using best practices and current technologies. Write clean, scalable, and efficient code in backend technologies such as JAVA, Node.JS, and .NET. Develop user-friendly interfaces using frontend frameworks like React and Angular. Collaborate with cross-functional teams to define, design, and ship new features. Implement and manage DevOps processes, including CI/CD pipelines, automated testing, and infrastructure as code. Participate in code reviews and contribute to a continuous improvement mindset. Stay updated with the latest industry trends and technologies to ensure our applications remain relevant and competitive. Provide technical support and troubleshooting for existing applications as needed. Requirements To be successful you should possess: Minimum of 2 years of professional experience in application development. Proficiency in backend technologies: JAVA, Node.JS, and .NET. Strong experience with frontend frameworks: React and Angular. Deep understanding of DevOps processes and best practices. Additional experience in Python is preferred. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Bachelor's degree in Computer Science, Information Technology, or a related field is preferred. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (hybrid). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. Requirements To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combination of education and experience. Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures. Strong written and verbal communication skills including good command of English and local language. Representative, outgoing and client focused. Ability to work in a fast-paced challenging environment of a growing company. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Effective clinical monitoring skills (all kind of visits mastered). Ability to perform travel an average of 8 days on site per month, depending on project needs. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Excellent understanding of the drug development process. Ability to proactively identify and resolve issues in a timely manner. Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. Effective organizational and time management skills. Ability to manage multiple projects and strong attention to detail. Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. Ability to meet project requirements. Proven flexibility and adaptability. Ability to work in a team or independently and to effectively prioritize tasks. Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (hybrid). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. Requirements To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combination of education and experience. Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures. Strong written and verbal communication skills including good command of English and local language. Representative, outgoing and client focused. Ability to work in a fast-paced challenging environment of a growing company. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Effective clinical monitoring skills (all kind of visits mastered). Ability to perform travel an average of 8 days on site per month, depending on project needs. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Excellent understanding of the drug development process. Ability to proactively identify and resolve issues in a timely manner. Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. Effective organizational and time management skills. Ability to manage multiple projects and strong attention to detail. Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. Ability to meet project requirements. Proven flexibility and adaptability. Ability to work in a team or independently and to effectively prioritize tasks. Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team (hybrid). The Submissions Senior Publishe are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications. In this role your key tasks will include: Manages submission timelines and activities for assigned projects to meet or exceed required deadlines Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes. Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate · Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality. Mentors less experienced Publishers and Submissions Specialists Assists with development and presentation of internal and sponsor training. With increasing knowledge and experience, manages and oversees submission processes. May interact with project teams to educate sponsors on technical requirements for submissions. With increasing knowledge and experience participates in submissions software evaluation, selection, and validation. Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities. Interacts with regulatory agency technical counterparts to resolve issues and Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types. Submissions Senior Publisher with direct line reports. Provides training to direct reports on current and new regulatory requirements for submissions/ Actively manages direct reports including development and performance management and Assists with evaluation of line report utilization and capacity. Actively participates in and leads staff learning & development within regulatory operations. Manages submissions team workload to meet or exceed sponsor deadlines. Coaches, mentors, and develops reports on collaborative consulting. Submissions Senior Publisher with or without direct line reports. Actively supports staff learning & development within the company. Provides guidance and advises Consulting Project Leads, and/or Project Teams on submissions requirements. Participates in meetings with clients to discuss submissions requirements. Provides mentorship to team members o Acts professionally with peers and clients, knows business etiquette. Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients · Provides regulatory operations input to proposals and bids. Actively manages, develops, and strengthens client relationships, drives repeat business. Contributes and take part in client evaluations, visits and bid defenses. Requirements To be successful you will possess: B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience. Strong regulatory knowledge of drug, biologic, or device development focusing on submission requirements. Strong communication skills (written and oral), commensurate with experience, to communicate effectively with a project team and clients, command of English language. Ability to manage multiple projects and team members to prioritize submissions based on regulatory and sponsor deadlines, complexity, and client cooperation Experience with formatting, publishing, and compiling simple and complex eCTD and other submission types Strong computer skills, including extensive experience with regulatory submissions software such as DocuBridge and ISI Toolbox, SharePoint, Word, Excel, and PowerPoint required RAC Certification preferred · >2 years' experience with submissions to US FDA, Health Canada, and European authorities Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team (hybrid). The Submissions Senior Publishe are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications. In this role your key tasks will include: Manages submission timelines and activities for assigned projects to meet or exceed required deadlines Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes. Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality. Mentors less experienced Publishers and Submissions Specialists Assists with development and presentation of internal and sponsor training. With increasing knowledge and experience, manages and oversees submission processes. May interact with project teams to educate sponsors on technical requirements for submissions. With increasing knowledge and experience participates in submissions software evaluation, selection, and validation. Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities. Interacts with regulatory agency technical counterparts to resolve issues and Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types. Submissions Senior Publisher with direct line reports. Provides training to direct reports on current and new regulatory requirements for submissions/ Actively manages direct reports including development and performance management and Assists with evaluation of line report utilization and capacity. Actively participates in and leads staff learning & development within regulatory operations. Manages submissions team workload to meet or exceed sponsor deadlines. Coaches, mentors, and develops reports on collaborative consulting. Submissions Senior Publisher with or without direct line reports. Actively supports staff learning & development within the company. Provides guidance and advises Consulting Project Leads, and/or Project Teams on submissions requirements. Participates in meetings with clients to discuss submissions requirements. Provides mentorship to team members o Acts professionally with peers and clients, knows business etiquette. Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients Provides regulatory operations input to proposals and bids. Actively manages, develops, and strengthens client relationships, drives repeat business. Contributes and take part in client evaluations, visits and bid defenses. To be successful you will possess: B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience. Strong regulatory knowledge of drug, biolo

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team in the Chennai location. The Senior Clinical Data Manager I (SrCDM1) will be responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, your key tasks will include leading and serving as the primary contact for DM with all relevant parties both internally and externally, planning and projecting the resources required, monitoring tasks against budgets and forecasts, and developing, reviewing, and maintaining project-specific DM documents. You will also lead and coordinate the development of clinical study database set-up, participate in the review of study documents, coordinate database User Acceptance Testing (UAT), create training materials for EDC users, oversee data cleaning and validation, and manage various data transfers and reconciliation activities. Additionally, you will provide project metric reports, status updates, study progress, and feedback to the project team, organize and lead Quality Review activities during the study, assist in project-related contracts negotiation, and manage the database maintenance, lock, and close-out processes. You will also participate in conference calls and meetings with vendors and sponsors, maintain DM study documentation, support internal and external audits, align data management and clinical programming best practices, and provide leadership and support to other department members. To be successful in this role, you should possess a life science or healthcare degree, a minimum of 5 years of relevant work experience as a Clinical Data Manager, thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and experience with electronic data capture software systems. You should also have experience as a DM lead on several studies, strong written and verbal communication skills, strong project management skills, and the ability to simplify complex issues into understandable concepts. Benefits of working at Allucent include a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, opportunity for remote/office-based working, leadership and mentoring opportunities, internal growth opportunities, access to online training, eligibility for Spot Bonus Award Program, and eligibility for Loyalty Award Program. Please note that office-based employees are required to work in-office for a minimum number of days per work week. Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.,

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent You will lead and coordinate clinical programming activities and maintaining clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards and regulatory requirements. You will be part of a small but nimble global team. Credibility, quality and collaborations are the key pillars that drive this team. We are looking for you to come with an innovative and can-do-approach where you can have a quick impact. In this role your key tasks will include: Design, build, test and release clinical databases to the production environment, including study design specifications, User’s Acceptance Test (UAT) test cases and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming. Review electronic Case Report Form (eCRF) Completion guidelines Develop and/ or validate SAS programs for metric reporting, data review listings, data import and data export set-up Support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models Review and adhere to the requirements of study-specific data management documents & plans Actively contribute/participate in study team, departmental meetings, sponsor meetings and uses analytical approach to problem solving Collaborate with peers, programmers, study teams to clarify specifications and uses expanded technical skills to meet evolving project needs Maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings etc. Research and propose initiatives for improving efficiency Develops and delivers applicable DM departmental trainings Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System Requirements To be successful you will possess: You bring a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution focused approach. To be successful we are looking for the following traits and behaviors: Good knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements. Good understanding of clinical data management processes and experience with tools and systems for managing clinical studies. Solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs and SDTM models). Strong programming SAS skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programming languages such as PL/SQL, SAS and comparable fields. Ability to work in a fast-paced challenging environment of a growing company. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices. “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*).The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Bengaluru Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 5 years of relevant work experience asa Clinical Data Manager. Minimum 5 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location). In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites) Plan and project the resources required including management of tasks, timelines, risk and quality Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks Create training materials for EDC users and provide project-specific training as required Review and validate clinical data to ensure consistency, accuracy, integrity and completeness Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA) Manage the database maintenance, lock and close-out processes and procedure Participate in conference calls and/or meetings with vendors and sponsors Recognize and solve potential problems and evaluate effectiveness Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned Help to align data management and clinical programming best practices, standards and conventions within the company Propose and support initiatives for improving efficiency. Requirements To be successful you will possess: Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification 6+ years' experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications. Good communication skills written and verbal. Effective working knowledge of Microsoft Office Suite including Word and Excel. Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills. Demonstrated flexibility and ability to work well in a fast-paced growing organization. Demonstrated ability to work in a global team environment. Demonstrates a basic understanding of Clinical Trials and the flow of data. Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs. Comprehension of study documentation standards including Trial Master File organization and archival processes. Familiarization of data standards, preferably CDISC STDM. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*).The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Chennai Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 5 years of relevant work experience asa Clinical Data Manager. Minimum 5 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent You will lead and coordinate clinical programming activities and maintaining clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards and regulatory requirements. You will be part of a small but nimble global team. Credibility, quality and collaborations are the key pillars that drive this team. We are looking for you to come with an innovative and can-do-approach where you can have a quick impact. In this role your key tasks will include: Design, build, test and release clinical databases to the production environment, including study design specifications, User's Acceptance Test (UAT) test cases and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming. Review electronic Case Report Form (eCRF) Completion guidelines Develop and/ or validate SAS programs for metric reporting, data review listings, data import and data export set-up Support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models Review and adhere to the requirements of study-specific data management documents & plans Actively contribute/participate in study team, departmental meetings, sponsor meetings and uses analytical approach to problem solving Collaborate with peers, programmers, study teams to clarify specifications and uses expanded technical skills to meet evolving project needs Maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings etc. Research and propose initiatives for improving efficiency Develops and delivers applicable DM departmental trainings Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System Requirements To be successful you will possess: You bring a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution focused approach. To be successful we are looking for the following traits and behaviors: Good knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements. Good understanding of clinical data management processes and experience with tools and systems for managing clinical studies. Solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs and SDTM models). Strong programming SAS skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programming languages such as PL/SQL, SAS and comparable fields. Ability to work in a fast-paced challenging environment of a growing company. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent, you will lead and coordinate clinical programming activities and maintain clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards, and regulatory requirements. You will be part of a small but nimble global team. Credibility, quality, and collaborations are the key pillars that drive this team. We are looking for you to come with an innovative and can-do approach where you can have a quick impact. In this role, your key tasks will include designing, building, testing, and releasing clinical databases to the production environment, including study design specifications, User's Acceptance Test (UAT) test cases, and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming, review electronic Case Report Form (eCRF) completion guidelines, develop and/or validate SAS programs for metric reporting, data review listings, data import, and data export set-up. You will also support the application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, review and adhere to the requirements of study-specific data management documents & plans, actively contribute/participate in study team, departmental meetings, sponsor meetings, and use an analytical approach to problem-solving. Collaborating with peers, programmers, study teams to clarify specifications, and using expanded technical skills to meet evolving project needs is also a key responsibility. Additionally, maintaining a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings, researching and proposing initiatives for improving efficiency, developing and delivering applicable DM departmental trainings, drafting and contributing as a Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes, and procedures within the Quality Management System are essential tasks. To be successful, you will possess a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare, and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution-focused approach. Good knowledge of ICH-GCP(R2), GDPR/HIPPA, and applicable (local) regulatory requirements, good understanding of clinical data management processes and experience with tools and systems for managing clinical studies, solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs, and SDTM models), strong programming SAS skills with proficiency in Electronic Data Capture (EDC) systems, data reporting, and programming languages such as PL/SQL, SAS, and comparable fields, ability to work in a fast-paced challenging environment of a growing company are important traits and behaviors we are looking for. Benefits of working at Allucent include a comprehensive benefits package per location, competitive salaries per location, departmental Study/Training Budget for furthering professional development, flexible working hours (within reason), opportunity for remote/office-based* working depending on location, leadership and mentoring opportunities, participation in our enriching Buddy Program as a new or existing employee, internal growth opportunities and career progression, financially rewarding internal employee referral program, access to online soft-skills and technical training via GoodHabitz and internal platforms, eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects, eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees. *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within a reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.",

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team. The Submissions Senior Publisher are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications. In this role your key tasks will include: Manages submission timelines and activities for assigned projects to meet or exceed required deadlines Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes. Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate · Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality. Mentors less experienced Publishers and Submissions Specialists Assists with development and presentation of internal and sponsor training. With increasing knowledge and experience, manages and oversees submission processes. May interact with project teams to educate sponsors on technical requirements for submissions. With increasing knowledge and experience participates in submissions software evaluation, selection, and validation. Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities. Interacts with regulatory agency technical counterparts to resolve issues and Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types. Submissions Senior Publisher with direct line reports. Provides training to direct reports on current and new regulatory requirements for submissions/ Actively manages direct reports including development and performance management and Assists with evaluation of line report utilization and capacity. Actively participates in and leads staff learning & development within regulatory operations. Manages submissions team workload to meet or exceed sponsor deadlines. Coaches, mentors, and develops reports on collaborative consulting. Submissions Senior Publisher with or without direct line reports. Actively supports staff learning & development within the company. Provides guidance and advises Consulting Project Leads, and/or Project Teams on submissions requirements. Participates in meetings with clients to discuss submissions requirements. Provides mentorship to team members o Acts professionally with peers and clients, knows business etiquette. Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients · Provides regulatory operations input to proposals and bids. Actively manages, develops, and strengthens client relationships, drives repeat business. Contributes and take part in client evaluations, visits and bid defenses. Requirements To be successful you will possess: B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience. Strong regulatory knowledge of drug, biologic, or device development focusing on submission requirements. Strong communication skills (written and oral), commensurate with experience, to communicate effectively with a project team and clients, command of English language. Ability to manage multiple projects and team members to prioritize submissions based on regulatory and sponsor deadlines, complexity, and client cooperation Experience with formatting, publishing, and compiling simple and complex eCTD and other submission types Strong computer skills, including extensive experience with regulatory submissions software such as DocuBridge and ISI Toolbox, SharePoint, Word, Excel, and PowerPoint required RAC Certification preferred · >2 years' experience with submissions to US FDA, Health Canada, and European authorities Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team. The Submissions Senior Publisher are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications. In this roleyour key tasks will include: Manages submission timelines and activities for assigned projects to meet or exceed required deadlines Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes. Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality. Mentors less experienced Publishers and Submissions Specialists Assists with development and presentation of internal and sponsor training. With increasing knowledge and experience, manages and oversees submission processes. May interact with project teams to educate sponsors on technical requirements for submissions. With increasing knowledge and experience participates in submissions software evaluation, selection, and validation. Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities. Interacts with regulatory agency technical counterparts to resolve issues and Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types. Submissions Senior Publisher with direct line reports. Provides training to direct reports on current and new regulatory requirements for submissions/ Actively manages direct reports including development and performance management and Assists with evaluation of line report utilization and capacity. Actively participates in and leads staff learning & development within regulatory operations. Manages submissions team workload to meet or exceed sponsor deadlines. Coaches, mentors, and develops reports on collaborative consulting. Submissions Senior Publisher with or without direct line reports. Actively supports staff learning & development within the company. Provides guidance and advises Consulting Project Leads, and/or Project Teams on submissions requirements. Participates in meetings with clients to discuss submissions requirements. Provides mentorship to team members o Acts professionally with peers and clients, knows business etiquette. Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients Provides regulatory operations input to proposals and bids. Actively manages, develops, and strengthens client relationships, drives repeat business. Contributes and take part in client evaluations, visits and bid defenses. Requirements To be successful you will possess: B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience. Strong regulatory knowledge of drug, biologic, or device development focusing on submission requirements. Strong communication skills (written and oral), commensurate with experience, to communicate effectively with a project team and clients, command of English language. Ability to manage multiple projects and team members to prioritize submissions based on regulatory and sponsor deadlines, complexity, and client cooperation Experience with formatting, publishing, and compiling simple and complex eCTD and other submission types Strong computer skills, including extensive experience with regulatory submissions software such as DocuBridge and ISI Toolbox, SharePoint, Word, Excel, and PowerPoint required RAC Certification preferred >2 years' experience with submissions to US FDA, Health Canada, and European authorities Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less