18 Ichgcp Jobs

At Allucent, we are dedicated to assisting small-medium biopharmaceutical companies in efficiently navigating the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. The Clinical Data Manager I (CDM1) plays a crucial role in supporting various data management activities within the Allucent Data Management (DM) department. This position involves collaborating with other Allucent Clinical Data Managers (CDMs) and Clinical Programmer(s) to ensure the quality standards and regulatory requirements for analysis and reporting are met. Your key tasks in this role will include: - Assisting in various data management tasks and collaborating with Lead DMs and relevant roles within Data Management - Providing feedback and status updates to Lead DM regarding progress, timelines, risk, and quality - Supporting the development, review, and maintenance of project-specific DM documents - Participating in database User Acceptance Testing (UAT) related tasks - Reviewing and validating clinical data to ensure consistency, accuracy, integrity, and completeness - Supporting various data transfers and reconciliation activities - Creating training materials for EDC users - Conducting Quality Review checks during studies and documenting findings - Supporting database maintenance, lock, and close-out processes - Identifying and solving potential problems and evaluating effectiveness - Maintaining DM study documentation and ensuring all filing is up to date - Supporting internal and external audits by collecting necessary documentation - Aligning data management and clinical programming best practices within the company - Proposing and supporting initiatives for improving efficiency and contributing to staff learning and development To be successful in this role, you will need: - A degree in life science, healthcare, or a related field - Minimum 6 months of relevant work experience in data management, CRA, or clinical database programming - Basic knowledge of ICH-GCP, GDPR/HIPPA, and regulatory requirements - Experience with electronic data capture (EDC) software systems and clinical study management tools - Strong communication skills and proficiency in English language - Ability to work in a fast-paced environment and attention to detail - Proficiency in computer applications such as Word, Excel, and PowerPoint The benefits of working at Allucent include a comprehensive benefits package, competitive salaries, training budget, flexible working hours, remote/hybrid working opportunities, leadership and mentoring programs, internal growth opportunities, and more. Please note that our hybrid work policy encourages a dynamic work environment, with 2 days in the office per week for employees within a reasonable distance from our global offices. Allucent does not accept unsolicited resumes from third-party recruiters. Candidates should not be submitted directly to our hiring managers or human resources.,

This is a supervisory position responsible for overseeing a team of eTMF Specialists, who are accountable for document upload and management in the electronic Trial Master File (eTMF) to support BMS Clinical Trials. As the supervisor, you will manage the allocation of workload among the team, ensuring tasks are completed efficiently and accurately. Your role involves overseeing the upload and quality reviews of electronic documents in the eTMF system to guarantee they are inspection-ready and compliant with the ICH/GCP and ALCOA Plus principles. You will be responsible for training and supervising the team to ensure they accurately complete attributes, metadata, and workflows for uploaded documents, enabling proper classification, management, identification, and accessibility for retrieval. Additionally, you will actively manage and develop direct reports by setting annual objectives, conducting mid-year and end-of-year evaluations, and providing necessary training on eTMF, procedural documents, and Health Authority regulations. Collaboration with various functions supporting clinical trial processes is essential to ensure regulatory requirements for maintaining compliant TMFs are met and to identify efficiency opportunities. Your responsibilities will also include maintaining knowledge of regulatory requirements and industry trends related to TMF compliance, addressing compliance gaps highlighted by Quality metrics and KPIs, and leading continuous improvement initiatives related to clinical trial documentation and TMF compliance. You will undertake remediation and training as needed to ensure eTMF documents meet user/requestor requirements. To qualify for this role, you must have a minimum of a bachelor's degree in Life Science, Business Administration, or equivalent experience, with an advanced degree being a plus. You should have 5-7 years of experience in health sciences or a related industry, including supervisory responsibility for eTMF. Strong knowledge of TMF, eTMF, and clinical document management systems, particularly Veeva Vault eTMF, is required. Proficiency in Excel, PowerPoint, SharePoint, and creating reports and dashboards in eTMF is essential. Comprehensive knowledge of local and international regulatory guidelines relevant to TMF Management is expected, along with the ability to provide TMF-related training and coaching to stakeholders. You should be well-versed in ALCOA Plus standards, Good Clinical Practice, Good Documentation Practices, and ICH guidelines. Experience in managing, leading, and developing employees, as well as collaborating with peers, is necessary. Additionally, you must possess strong organizational, technical, analytical, problem-solving, and critical thinking skills. Excellent communication and interpersonal skills are crucial for interacting effectively at all levels of the organization. Strong leadership, people management, time management, and project management skills are required. You should be adaptable, proactive, and motivated for continuous learning and organizational development, with a keen interest in quality review processes and decision-making.,

Precision for Medicine is looking for a skilled Medical Coder to provide comprehensive Coding and related data management support during all phases of the clinical trial data management process. Working under direct supervision with a team of medical coders, you will ensure compliance with Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role involves various responsibilities, including data coding, quality review, and collaboration within a dynamic team environment. The Coder will be responsible for providing Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full-time basis. They will follow Standard Operating Procedures/Work Instructions (SOPs/WIs), regulatory directives, and study-specific plans and guidelines. This position involves performing Coding quality reviews and working closely with the Coding Manager to prioritize coding tasks for timely completion. Key responsibilities of the job include but are not limited to: - Conducting medical coding of medical terms to ensure logic and consistency (MedDRA and WHODRUG) - Supporting other team members as needed, ensuring tasks are completed promptly - Performing quality control of Coding - Providing input into Coding timelines for overall deliverables - Meeting clinical data coding deadlines with quality - Reviewing feedback from stakeholders - Conducting coding dictionary upgrade UAT and maintaining quality-controlled documentation - Creating, revising, versioning, and maintaining data management coding documentation - Training clinical research personnel on study-specific Coding related items - Reviewing and querying coding data as per the Data Management Plan and Coding standards - Running coding status and metric reporting - Assisting in the development and maintenance of SOPs and process documentation related to coding activities - Ensuring all team members have received sufficient training - Communicating with study sponsors and project teams as required - Conducting coding demonstrations/trainings and participating in department/company training sessions and project meetings - Performing other assigned duties Requirements: - Minimum of 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - At least 2 years of experience in performing Dictionary medical coding (MedDRA and WHODrug) - Proficiency in Microsoft Office applications - Strong organizational and communication skills - Basic knowledge of drug, device, and/or biologic development and data management practices Preferred Qualifications: - Experience in a clinical, scientific, or healthcare discipline - Oncology and/or Orphan Drug therapeutic experience Skills: - Demonstrated knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance - Ability to implement and drive outcomes Precision Medicine Group ensures that any data provided as part of the application process will be stored in accordance with its Privacy Policy. For CA applicants, please refer to the CA Privacy Notice. Individuals with disabilities requiring accommodations during the application process may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please note that the organization follows a formal interview process and communicates directly with candidates before extending a job offer to prevent fraudulent activities by unauthorized individuals or organizations.,

As a Sr CRA I based in Beijing at Syneos Health, you will play a crucial role in monitoring clinical research studies to ensure they are conducted in line with established clinical practices. You will be responsible for both on-site and remote monitoring, developing tools, procedures, and processes to maintain quality monitoring standards. Your dedication to contributing to the design, implementation, and delivery of processes and programs will be instrumental in the success of clinical research studies. Syneos Health is committed to fostering a supportive and engaging work environment where career development, progression, and peer recognition are prioritized. As part of our Total Self culture, you will be encouraged to be your authentic self as we believe that diversity of thoughts, backgrounds, and perspectives contributes to a workplace where everyone feels a sense of belonging. In your role, you will ensure regulatory compliance throughout various stages of clinical trials such as site qualification, initiation, monitoring, management, and close-out visits. Your duties will also include evaluating site performance, protecting patient confidentiality, verifying clinical data accuracy, and managing site-level activities to meet project objectives and timelines. At Syneos Health, you will have the opportunity to collaborate with a team of passionate problem solvers who are dedicated to accelerating the delivery of therapies and changing lives. With a global presence across 110 countries and a diverse workforce, you will be part of a company that is continuously evolving to create a workplace that employees are proud to be a part of. If you are a motivated individual with a background in clinical monitoring and a commitment to upholding the highest standards of clinical research practices, we invite you to join us in our mission to make a meaningful impact on healthcare outcomes. Please note that the responsibilities listed in this job description are not exhaustive and additional tasks may be assigned at the company's discretion. Qualifications may vary based on equivalent experience, skills, and education. Syneos Health is an equal opportunity employer committed to compliance with all applicable regulations and ensuring a supportive and inclusive workplace for all employees.,

As a Senior Clinical Operations Specialist (Senior CTA) in the Hybrid model in Athens at Syneos Health, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include assisting Clinical Monitoring staff with site management activities, maintaining project files, handling project correspondence, participating in file audits, and preparing and maintaining site manuals and reference tools. Additionally, you will be responsible for updating clinical tracking information into databases, tracking documents, managing the shared mailbox, and coordinating site supplies and materials. You will collaborate with sites on assigned studies, communicate with them to ensure compliance with protocol requirements and relevant guidelines, and serve as a Sponsor representative. Your role will also involve anticipating, identifying, and resolving potential issues, implementing corrective actions, and seeking guidance as needed for more complex matters. Furthermore, you will participate in team meetings, prepare accurate meeting minutes and action items, and maintain awareness of clinical research by completing all necessary training. To excel in this role, you should preferably have an Associate's degree or equivalent experience in clinical research, pharma, biotech, or a related field. Good knowledge of medical terminology, clinical data, and ICH/GCP is preferred. You should possess strong organizational skills, attention to detail, and the ability to prioritize and work on multiple tasks. Excellent communication, presentation, and interpersonal skills are essential, along with the willingness to embrace new technologies. Minimal travel of up to 10% may be required as part of your responsibilities. At Syneos Health, we are committed to developing our employees through career progression, supportive line management, training programs, peer recognition, and a total rewards program. Our Total Self culture encourages authenticity and fosters a sense of belonging among our diverse workforce. By joining us, you will become part of a team dedicated to accelerating the delivery of therapies and changing lives. Syneos Health has a strong track record, having worked on a significant number of FDA-approved drugs, EMA authorized products, and numerous studies across various sites and trial patients. In our dynamic and competitive environment, you will be empowered to challenge the status quo and drive innovation. If you are passionate about making a difference in the field of clinical research and are looking for a challenging yet rewarding opportunity, consider joining Syneos Health. Learn more about us at http://www.syneoshealth.com.,

Are you ready to make a significant impact in the world of Biopharma Clinical Operations As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge Design, develop, implement, maintain, continuously improve, and provide ongoing customer support. Manage lifecycle of all system documents ensuring compliance with industry regulations and AstraZeneca policies. Communicate effectively and timely, providing high-quality training materials. Provide training, advice, and end-user support. Engage and influence key partners to drive strategy, development, and continuous improvement. Understand, evaluate, prioritize, and address customer requirements. Supervise performance by defining, tracking, and using key performance indicators for process improvements. Support audit and regulatory inspection planning, preparation, and conduct. Promote creative and innovative ideas to drive performance and deliver new solutions to customers. Essential Skills/Experience: - Bachelors of Science in an appropriate subject area or equivalent experience - Extensive knowledge of Drug Development within a pharmaceutical or clinical background - High level of business process, technology and Clinical Study information experience - Demonstrated project management skills to deliver to time, cost and quality - Ability to collaborate with, motivate and empower others to accomplish objectives - Experience working successfully with external partners delivering mutual benefit - Excellent written, verbal, influencing skills; negotiation, teamwork, problem solving, presentation skills - Experience in Medidata Rave including iMedidata user and site administration Desirable Skills/Experience: - Expert reputation within the business and industry - Experience using standard process improvement methodologies (e.g. Lean Six Sigma) - Experience in development and management of Business Processes for performance delivery - Comprehensive knowledge of ICH/GCP - Extensive experience in Validation of computerised systems in a regulated environment - Extensive experience of Quality Systems and Quality Management - Medidata Study Builder certification - Experience in other EDC systems (e.g Veeva, Bioclinica) - Experience in other Medidata products including Rave EDC When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll find yourself in an environment that values transparency and expertise. Here, you can apply your skills across various functions to make decisions that prioritize patients. With a focus on continuous improvement and innovation, you'll be supported by leaders who empower you to work on initiatives that benefit both you and the business. Embrace global opportunities as you supply to research that makes a tangible difference worldwide. Ready to take on this exciting role Apply now and become part of our diverse team! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.,

The Senior Analyst II role involves developing and maintaining Tableau dashboards and utilizing SQL programming to support clinical data management and analysis. A strong technical background and understanding of clinical trial domains are essential. Responsibilities include designing interactive Tableau dashboards, optimizing SQL databases, analyzing study requirements, managing data discrepancies, collaborating with clinical teams, ensuring data quality, and providing technical documentation. The role also involves troubleshooting data-related issues and staying updated on industry best practices. Qualifications: - Minimum of a 4-year college degree in a relevant discipline - 5 years of experience in a similar role, preferably in a clinical or healthcare setting - Proficiency in Tableau, Excel, and SQL - Knowledge of clinical trial domains and data management principles - Strong analytical and problem-solving skills - Excellent communication skills - Attention to detail and commitment to data accuracy Preferred qualifications include experience with other data visualization tools, knowledge of programming languages like Python or R, familiarity with clinical trial data and regulatory requirements, and certification in data management or related fields. Skills required for the role: - Strong interpersonal skills - Familiarity with ICH-GCP and relevant Precision SOPs - Self-motivation and ability to work independently and in a team - Professionalism in interactions with stakeholders - Efficient and professional verbal and written communication Competencies include demonstrating Precision Values and Company Principles, maintaining professionalism, punctuality, and positive interactions, and adhering to data privacy policies. Any data provided during the application process will be handled in accordance with the Privacy Policy. It is also emphasized that job offers will only be extended after proper communication and formal interviews with the recruiting team and hiring managers.,

At Allucent, you will play a crucial role in helping small-medium biopharmaceutical companies navigate the world of clinical trials to deliver life-changing therapies to patients worldwide. As a Sr. Clinical Research Associate Contractor (Sr.CRA) on our remote A-team, you will have the opportunity to independently manage and monitor investigational sites, ensuring adherence to trial protocols, SOPs, regulations, and Good Clinical Practice standards. Your responsibilities will include maintaining the highest quality standards for trial monitoring activities, overseeing site activities to ensure protocol compliance, preparing detailed reports, updating CTMS systems, and providing support to the project team. You will also collaborate with stakeholders to track study progress, supervise data collection, and identify and address logistical challenges effectively. To excel in this role, you must have at least five years of clinical monitoring experience, a relevant life science degree or equivalent background, and a strong grasp of Good Clinical Practices and SOPs. Excellent communication skills, both written and verbal, proficiency in computer applications, and the ability to travel on-site as needed are essential. Your understanding of clinical trials, drug development processes, and medical terminology will be key to your success. At Allucent, we offer a comprehensive benefits package, competitive salaries, professional development opportunities, flexible working hours, and a supportive work environment that values growth and career progression. Join us to be part of a team dedicated to making a difference in the field of medical research. Please note that office-based employees are required to work in-office a minimum of two days per work week, with exceptions based on specific roles and locations. We do not accept unsolicited resumes from third-party recruiters and appreciate direct applications from interested candidates.,

As a Manager in GCS Business Technology Solutions at AstraZeneca, you will play a crucial role in leading and innovating in the realm of Biopharma Clinical Operations. Your primary responsibility will be to design, develop, and continuously improve processes, systems, and services that drive clinical study delivery. You will collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilizing tools like Lean Six Sigma, you will identify and implement improvements to ensure optimal end-to-end delivery. Are you ready to make a difference in this dynamic and challenging role Your key accountabilities will include designing, developing, implementing, maintaining, and continuously improving systems while providing ongoing customer support. You will be responsible for lifecycle management of all system documents, ensuring compliance with industry regulations and AstraZeneca policies. Effective communication of information and provision of high-quality training materials will be essential aspects of your role. Additionally, you will provide training, advice, and end-user support, engage and influence key partners to drive strategy, development, and continuous improvement, and oversee EDC User Accesses and periodic reviews. Your role will also involve supporting audit and regulatory inspection planning, preparation, and conduct, delivering Corrective and Preventive Actions in a timely manner, and promoting creative and innovative ideas to drive performance and bring new solutions to customers. You will need to have a Bachelor of Science in an appropriate subject area or equivalent experience, extensive knowledge of Drug Development within a pharmaceutical or clinical background, and high-level business process, technology, and Clinical Study information experience. Moreover, you should possess demonstrated project management skills to deliver to time, cost, and quality, ability to collaborate with, motivate, and empower others to accomplish objectives, and experience working successfully with external partners delivering mutual benefit. Excellent written and verbal communication skills, negotiation, collaboration, problem-solving, presentation, mentoring, conflict management, and interpersonal skills are crucial for this role. Experience in Medidata Rave, including iMedidata user/site administration, report administration, core configuration, study build/edit check programming, is an essential requirement. Desirable skills and experience include having an expert reputation within the business and industry, experience applying standard process improvement methodologies like Lean Six Sigma, and comprehensive knowledge of ICH/GCP. Extensive experience in Validation of computerized systems in a regulated environment, Quality Systems, and Quality Management, as well as certifications in Medidata Study Builder and experience in other EDC systems like Veeva and Bioclinica, will be advantageous. Experience working within an agile environment using JIRA is also desirable. AstraZeneca values diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible. Join us in our mission to explore the possibilities of science, make a difference, and work towards treating some of the world's most complex diseases. If you are ready to make an impact and thrive in a collaborative and innovative environment, apply now to join our team! Date Posted: 04-Aug-2025 Closing Date: 24-Aug-2025,

As a Data Management Specialist, you will be responsible for designing and reviewing Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. You will develop and maintain Data Management Plans (DMPs), data validation specifications, edit checks, and coding guidelines. Your role will involve overseeing data entry, data cleaning, discrepancy management, and query resolution processes to ensure data integrity. It will be your responsibility to ensure compliance with industry standards such as CDISC (CDASH, SDTM) and regulatory guidelines from FDA and ICH-GCP. You will be involved in conducting User Acceptance Testing (UAT) of EDC systems and monitoring data quality throughout the project lifecycle. Additionally, you will work towards achieving timely database lock in accordance with project schedules. This is a full-time and permanent position suitable for fresher candidates. The benefits of this role include health insurance, paid sick time, and Provident Fund. The work location for this role is in person, where you will collaborate with a team to achieve data management goals efficiently.,

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variables, value specifications and coding standards, and in monitoring the quality of data management processes, data, and performance. Review and provide inputs to CRF design and CRF Completion Instructions, database design, data management/data validation plans, data entry guidelines, and revisions to the Standard Operating Procedures. Manage resource planning methodologies and project management to ensure study deliverables and timelines are met in collaboration with the Sponsor, the Sponsor change order process, and to ensure effective communication exchange between the multidisciplinary project teams. Assist/Work with Sr. Management in identifying, developing, and implementing processes to improve/enhance time and cost efficiencies, to provide current information and potential impact of changes on project deliverables and timelines, to identify trouble-shoot issues and provide proposed solutions for problem resolution, to evaluate future potential data management solutions (e.g. functional service provider models, EDC systems) and prepare a business plan, to individual development, training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars, and to endorse and convey QED's corporate mission statement. Qualifications/Experience: - Bachelor's/Master's degree in computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required. - Direct management of employees within Clinical Data Management is preferred.,

The Manager 2-Clinical Data Management at Sun Pharmaceutical Industries Ltd in Gurgaon - R&D is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations. The incumbent will be managing all data management aspects of assigned project(s) from setup to lock, attending regular meetings with the project team to discuss data management issues, and providing status updates. Reporting on quality and performance metrics, including timelines, to project leads and other stakeholders is also a key responsibility. Participation in in-house and external training courses when required, preparation/review of Data Management process control documents such as Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, and Coding Guidelines is expected. Additionally, coordinating and managing training and EDC access for investigators, coordinators, data entry, and CRAs on selected applications for data entry, cleaning, and running reports as applicable to study parameters. Reviewing, freezing, and/or locking data in accordance with Data Management documents for accuracy, completeness, consistency, and validity, generating queries as necessary, coordinating with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, and maintaining Data Management study documentation in an audit-ready status are essential duties. Reconciliation, including SAS/AE, Electronic Data Files (EDF), and third-party data against the clinical database, and tracking issues to resolution is also part of the role. The Manager 2-Clinical Data Management may present at investigator meetings and PM/CRA training sessions, as well as identify and recommend process improvements to the management team. The geographic scope for this position is global, and it is a full-time role with infrequent travel requirements. The ideal candidate should preferably have a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science, or related discipline, along with a minimum of 6 years of clinical data management experience including working knowledge using clinical data capture tools. Experience of leading global clinical studies is preferred.,

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user requirements documents, functional specifications, and testing scripts - Interacting with end-users to create specifications and work with programmers for successful delivery - Offering quantitative analytical support to global program teams and assisting in analyzing reports - Supporting the planning, execution, and close-out of Clinical Programs/Trials - Collating and delivering analytics reports for critical decision-making purposes - Maintaining appropriate documentation and working with internal SMEs and key stakeholders to analyze clinical program/trial operational data - Providing training to end-users on the best use of various data review tools - Programming reports of varying complexity within clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R - Demonstrating good knowledge of Novartis Clinical Data Standards for creating report specifications or outputs - Supporting special projects of limited scope, both clinical and non-clinical - Offering study-level expertise and involvement in CTTs - Leading or supporting special projects across various responsibilities, such as systems issues, processes, user support, and training Your performance will be evaluated based on: - Quality and timeliness of deliverables - Revisions to deliverables due to logic or programming errors - Customer feedback and satisfaction To be successful in this role, you should have: - At least 5-7 years of experience in clinical review, reporting programming, business analytics, or clinical trial setup in the pharmaceutical, CRO, or Life Science industry - Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) - Familiarity with Data Review and/or Business Intelligence tools (e.g., Spotfire, JReview) - Understanding of clinical data management systems and relational databases applied to clinical trials - Attention to detail, quality, time management, and customer focus - Ability to communicate technical concepts to non-technical users - Strong verbal and written communication skills for global collaboration - Knowledge of Drug Development Process, ICHGCP, CDISC standards, and Health Authority guidelines - Capability to train and supervise new or less experienced associates Novartis offers a supportive community of smart, passionate individuals dedicated to making a difference in patients" lives. If you are ready to contribute to breakthroughs that change lives, join us in creating a brighter future together. For more information about Novartis and to explore career opportunities, visit: https://www.novartis.com/about/strategy/people-and-culture If you are interested in staying connected with Novartis for future career opportunities, sign up for our talent community: https://talentnetwork.novartis.com/network To learn about the benefits and rewards of working at Novartis, read our handbook: https://www.novartis.com/careers/benefits-rewards Novartis is committed to fostering an inclusive work environment and diverse teams that reflect the patients and communities we serve. If you require accommodation due to a disability, please contact [email protected] with your request and contact information, including the job requisition number.,

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.",

Job Title: Medical Data Abstractor (MDA) Department: Delivery Job Location: Turbhe, Navi Mumbai (Work from Office) Reporting To: Lead Job Duties / Responsibilities: Data management and Curation Performs complex data abstraction (i.e. requiring interpretation) and data entry for specified disease and project requirements. Participates and contributes to team meetings and learning sessions. Maintains a high level of medical knowledge and terminology and expertise of electronic medical record and data capture systems. Self-reports activities like time spent on records, audits completed including all relevant details and any other reporting functions assigned by Operations and QA management teams. Quality Assurance Consistently complies with minimum quality levels indicated in the QA plan for each project (>95% or higher accuracy depending on the project). Receives feedback from Quality Analyst and ensures timely reconciliation of errors. Participates in quarterly Inter rater reliability (IRR). Special Projects May lead or participate in special projects or client-specific initiatives as directed. Education and Experience: Graduate / PG - Medicos: BDS, MDS, BAMS, BUMS, BHMS, BPT, MD. 0-5 years of experience in the clinical or non-clinical field. Should be presentable and pleasant. Ability to multitask, work under pressure, and meet deadlines required.,

You will be responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance with SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP, and local regulations. Your duties will include managing all data management aspects of assigned project(s) from setup to lock. You will attend regular meetings with the project team to discuss data management issues and provide status updates for the project. Reporting on quality and performance metrics, including timelines, to project leads and other stakeholders will also be part of your responsibilities. You will participate in in-house and external training courses as required. Additionally, you will be involved in the preparation/review of Data Management process control documents such as Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, and Coding Guidelines. Coordinating and managing training and EDC access for investigators, coordinators, data entry, and CRAs on selected applications for data entry, cleaning, and running reports will be essential. You will review, freeze, and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency, and validity, generating queries as necessary for sites and/or the project team. Furthermore, you will coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology as required. Maintaining Data Management study documentation in an audit-ready status and performing reconciliation against the clinical database will also be part of your role. You may be required to present at investigator meetings and PM/CRA training sessions and identify and recommend process improvements to the management team as identified. This role has a global geographic scope/market and is a full-time position. The physical requirements include being present at work, and travel estimates are infrequent. Ideally, you should have a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science, or related discipline. For the Executive position, a minimum of 3 years of clinical data management experience is required, including working knowledge using clinical data capture tools. For the Sr. Executive position, a minimum of 5 years of clinical data management experience is required, including working knowledge using clinical data capture tools. Experience of leading global clinical studies is preferred.,