652 Clinical Trials Jobs - Page 20

The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables in Novartis Global Drug Development. Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. 2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. 3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), eg as member of the extended Clinical Trial Team (CTT). 4. Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. 5. Comply with company, department and industry standards (eg CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. 6. Provide and implement statistical programming solutions; ensure knowledge sharing. 7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (eg SAS) as we'll as industry requirements (eg CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. As assigned, act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators (Indicate how performance for this job will be measured) : Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Program Statistician and the functional/operational manager. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. Job Dimensions (Indicate key facts and figures) Number of associates: No direct reports. Coordination of 5+ internal and external programmers. Financial responsibility: (Budget, Cost, Sales, etc) None Impact on the organization: Timely, high quality and efficiently produced statistical programming deliverables included in study and project level documents (incl. submissions) Reliable and compliant statistical analysis results presented externally (incl. submissions) Innovative technical solutions to support timely and efficient drug development deliverables Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional requirement: Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISC data structures as we'll as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (eg GCP, study procedures). Good communications and negotiation skills, ability to work we'll with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry

-Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing Major accountabilities: Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards. Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development. May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendation for trial inclusion. Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD). Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Adherence to Novartis policy and guidelines and external regulations Minimum Requirements: Work Experience: Operations Management and Execution. Project Management. Financial Management. Collaborating across boundaries. Skills: Trial Planning and Feasibility. Over The Counter Product Development. Post Authorization Data Safety. Regulatory Strategy. Clinical Trial Set-up, Management Conduct. Languages : English.

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics

We are in search of a Senior Principal Statistical Programmer, with expertise in HTA and Pricing and Reimbursement activities. This role offers the chance to provide statistical programming solutions to HTA problems. The successful candidate will work closely with International Value Access and HEOR teams to shape ways of working for Joint Clinical Assessment in Europe to ensure high-quality deliverables. -The Senior Principal Statistical Programmer will be responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting compliance with timelines. About the Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. 3. May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes. 4. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), eg as SP representative in study- or project-level team. 5. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. 6. Comply with company, department and industry standards (eg CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). 7. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (eg SAS) as we'll as industry requirements (eg CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Key performance indicators: 1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, 2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team/ project level meetings. Effectiveness of communication and team behaviors as assessed by the team members. 3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. 4. Ability and effectiveness as a programming representative on non-clinical initiatives. Minimum Requirements: Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional requirement: 1. Strong programming skills in R and Python and SAS. Demonstrated knowledge of data visualization , exploratory analysis. 2. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications 3. Advanced knowledge of industry standards including CDISC data structures as we'll as a solid understanding of the development and use of standard programs 4. Good understanding of regulatory requirements relevant to Statistical Programming (eg GCP, study procedures) 5. Proven communications and negotiation skills, ability to work we'll with others globally and influence 6. Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others 7. Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry 8. Experience in HTA /HEOR is preferable

The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and postmarketing activities) The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables. Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. 3. May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes. 4. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), eg as SP representative in study- or project-level team. 5. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. 6. Comply with company, department and industry standards (eg CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). 7. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (eg SAS) as we'll as industry requirements (eg CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Key performance indicators: 1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers. 2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team/ project level meetings. Effectiveness of communication and team behaviors as assessed by the team members. 3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. 4. Ability and effectiveness as a programming representative on non-clinical initiatives. Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional requirement: Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as we'll as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (eg GCP, study procedures) Proven communications and negotiation skills, ability to work we'll with others globally and influence Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry.

The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and postmarketing activities) The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables. Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. 3. May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes. 4. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), eg as SP representative in study- or project-level team. 5. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. 6. Comply with company, department and industry standards (eg CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). 7. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (eg SAS) as we'll as industry requirements (eg CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures Key performance indicators: 1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers. 2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team/ project level meetings. Effectiveness of communication and team behaviors as assessed by the team members. 3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. 4. Ability and effectiveness as a programming representative on non-clinical initiatives. Minimum Requirements: Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field. Languages: Fluent English (oral and written). Experience/Professional requirement: Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as we'll as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (eg GCP, study procedures) Proven communications and negotiation skills, ability to work we'll with others globally and influence Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry.

The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and / or Medical Expert TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (eg, Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. Contributes to clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Advocate continuous improvement of quality Key performance indicators: Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations. Evidence of quality medical and scientific review of clinical trial data Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (eg CSR), and regulatory documents (eg IB, DSUR). Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine / pharmacology etc) with medical council certification required. Experience in hematology / oncology preferred. Work Experience: At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. Clear written and verbal expression of ideas, an active/proactive communicator. we'll-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages : English.

-Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission. About the Role Major accountabilities: Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions. Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses. May serve as local HA liaison depending on location (eg, FDA or EMA). Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans. May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL. Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data. Identification of main HA issues -Participation in relevant regulatory Boards leading to valuable input from these Boards. Successful Participation in HA interactions to achieve business objectives. Adherence to Novartis policy and guidelines -Project stakeholder feedback Minimum Requirements: Work Experience: Functional Breadth. Cross Cultural Experience. Operations Management and Execution. Project Management. Skills: Clinical Trials. Detail Oriented. Drug Development. Lifesciences. Negotiation Skills. Regulatory Compliance. Languages : English.

We are seeking a highly skilled Clinical Statistician with extensive experience in CDISC-compliant statistical programming. The ideal candidate will be responsible for providing statistical support for individual clinical trials as we'll as integrated summaries of safety (ISS) and efficacy (ISE). This role requires a deep understanding of clinical trial design, data analysis, and regulatory requirements. Key Responsibilities: Develop and execute statistical analysis plans for clinical trials. Perform statistical programming using SAS and R, ensuring compliance with CDISC standards. Conduct integrated analyses for ISS and ISE, ensuring consistency and accuracy across studies. Leverage experience (if applicable) to support the preparation of datasets and documentation for regulatory submissions, such as ISS/ISE, in line with global standards (eg, FDA, EMA) Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and regulatory submissions. Collaborate with cross-functional teams, including clinical research, data management, and medical writers, to ensure accurate and timely delivery of statistical outputs. Provide statistical input for study design, protocol development, and sample size calculations. Review and validate statistical deliverables to ensure quality and compliance with regulatory guidelines. Stay current with industry trends and advancements in statistical methodologies. Contribute to process optimization and development of templates, or standardized processes to enhance team efficiency and consistency. Qualifications: Masters or Ph.D. in Statistics, Biostatistics, or a related field. Minimum of 5 years of experience in clinical statistics, with a focus on CDISC-compliant statistical programming. Proficiency in SAS and R programming, in aim of increasing efficiency. Experience with integrated summaries of safety (ISS) and efficacy (ISE). Strong understanding of clinical trial design, data analysis, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment. Ability to manage multiple projects and meet deadlines in a fast-paced environment. Preferred Qualifications: Experience in the pharmaceutical or biotechnology industry. Knowledge of other programming languages (eg, Python) is a plus. Familiarity with regulatory submission processes (eg, FDA, EMA). Experience in management, Agile/scrum-type experience is a plus. Experience of working with international teams remotely is a plus.

-Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting compliance with timelines. About the Role Major accountabilities: Lead statistical programming activities for several studies or drive the implementation of data analytics reports -Make decisions and propose strategies at study or project level. May act as functional manager for local associates including providing supervision and advice on functional expertise and processes. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), eg as representative in study or project-level team. Ensure project-level standardization -Provide and implement programming solutions; ensure knowledge sharing. Act as expert in problem-solving aspects. Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc -Leads/co leads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience: Biostatistics. Clinical Research Phases. RD Portfolio Management. Statistical Programming. Data Management Systems. Regulatory Submissions. Innovative Analytical Technologies. Clinical Trial Design, Data Review Reporting. Skills: Classification Systems. Clinical Trials. Computer Data Storage. Computer Programming. Cross-Functional Teams. Data Analysis. Data Structures. Initiative. Programming Languages. Reporting. Statistical Analysis. Languages : English.

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned. Major accountabilities: Implementing issue resolution plans; -Assist with program level activities (eg, tracking of program -Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Applicable for Clincial Scientific Expert I: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready. High quality contributions to study documents (eg protocol, ICF, clinical sections of CTA) -Clearly demonstrates Novartis Values and Behaviors (ie Innovation, Quality, Collaboration, Performance, Courage and Integrity. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Clinical Research. Clinical Trial Protocol. Clinical Trials. Data Integrity. Learning Design. Lifesciences. Risk Monitoring. Trends Analysis. Languages : English.

-Responsible for all statistical programming/data review reporting and analytics development aspects of assigned studies or project-level activities. Acts as a key contributor in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Major accountabilities: Responsible for planning, monitoring, documenting of projects and analysis of information -Co-ordinate activities of all programmers either internally or externally assigned to the study/project work -Contribute to project level standards -Review and discuss data structures and participate in data review activities. Responsible for development of programming specifications of analysis datasets or user requirement documentation -Contributes to some cost center goals and objectives -Broadens technical knowledge via departmental activities, literature reading and experiential learning. May train junior. new team members -Skilled in collaboration across project team(s) -Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience: Biostatistics. Clinical Research Phases. RD Portfolio Management. Innovative Analytical Technologies. Regulatory Submissions. Data Management Systems. Statistical Programming. Clinical Trial Design, Data Review Reporting. Skills: Clinical Trials. Computer Programming. Data Analysis. Programming Languages. Reporting. Statistical Analysis. Languages : English.

Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues Major accountabilities: Close interaction and collaboration with study team lead and study team members during study lifetime. Review of vendor related protocol sections during protocol development Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion. Manages interface with vendors in cooperation with vendor partner functions Quote/proposal review in collaboration with procurement, support contract negotiations, Contributes to the development of vendor contract amendments. Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out Creates and maintains vendor-related risk maps with contingency plan for documentation. Key performance indicators: Timely, efficient and quality execution of trials trial related activities within assigned clinical program(s) within budget, and in compliance with quality standards. Adherence to Novartis policy and guidelines and external regulations. Minimum Requirements: Work Experience: Excellent knowledge of the clinical operation processes and vendor management. Critical Negotiations. Collaborating across boundaries. Operations Management and Execution. Skills: Budget Management. Clinical Trials. Negotiation Skills. Process Improvement. Project Management. Project Planning. Vendor Management. Languages : English.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Job Summary: The Senior Solution Architect is responsible for defining end to end solutions and / or business offerings to meet the functional and non-functional requirements of the end customer while ensuring it is costed, delivered to specification and can be operated. It is the Solution Architects role to ensure that all elements of the solution are delivered including the business, application, technology layers while complying to information and security requirements and provision an operational service by directing the domain and functional experts within each of these domains. We are seeking a highly skilled and experienced Senior Solutions Architect to join our team. The ideal candidate will be an expert in building modern PaaS and SaaS platforms, following agile architecture and leveraging cloud-native technologies, particularly Azure. They will have a strong background in the life sciences and clinical trials segment and a proven track record of leading change and adopting new technologies, such as AI, to deliver high-quality designs to engineering teams. Key Responsibilities: Lead the development of end-to-end solutions that meet functional and non-functional requirements. Ensure the delivery of business, application, and technology layers while complying with information and security requirements. Provide technical leadership and guidance to architects, engineering teams, and other related functions. Drive the adoption of agile methodologies and cloud-native technologies, particularly Azure. Lead the implementation of new technologies, such as AI, to accelerate solution delivery. Collaborate with stakeholders to define and prioritize requirements and manage competing priorities. Conduct risk assessments and develop countermeasures and contingency plans. Monitor emerging technologies and evaluate their potential impact on our solutions. Qualifications: Bachelors Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or equivalent project-related experience. Demonstrable experience in technical delivering utilising modern SaaS Platforms with a proven record in design and architecture activities. Certification in agile delivery (e.g., SAFe, Scrum) and design methodologies (e.g. TOGAF, UML). Expertise in cloud-native technologies, particularly Azure, including Service Bus, PaaS DBs, Azure Functions and Containers. Experience with medical imaging and DICOM. Knowledge of the life sciences and clinical trials segment is highly desirable, as is any experience in AI-driven image analysis and machine learning algorithms for medical imaging. Excellent interpersonal, verbal, and written communication skills. Ability to manage multiple tasks with enthusiasm and prioritize workload with attention to detail. Strong initiative, self-confidence, and adaptability to cope with changing priorities. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Skills: 4+ years of working experience as Product Owner; Agile experience and Medical Imaging Experience Job Summary: As a Senior Product Owner, your role sits within the Product Group and is responsible for facilitating the generation and maximization of value from our products and services for our customers, both internal and external. You will take accountability for the delivery of large initiatives (projects / epics / capabilities). Your role involves translating the product roadmap into a delivery roadmap, ownership of the Team Backlog (user stories) delivering the features (via user Stories) for your assigned product, solution or epic, prioritizing the work, working closely and directly with agile delivery teams, participating in SAFe and scrum ceremonies, functionally guiding other Product Owners to completion and overseeing the end to end delivery process to execute the product requirements. Key Responsibilities Product Backlog Management Requirements: Takes ownership of team backlog (user stories) and breaks down features into user stories for one or more products/ applications. Takes ownership for work on large initiatives (epics/capabilities) and assists with more complex change initiatives. Elicits, identifies, documents, and refines requirements from business problems detailed in features into user stories and acceptance criteria that may include technical requirements. Ensures Non-Functional requirements are captured and recorded in the acceptance criteria in user stories. Prioritizes the user stories in the product backlog (with business stakeholders and Product Manager), to ensure the items with the highest business value are at the top of the backlog and being worked on by the delivery team. Ensures the product backlog is clearly communicated to business stakeholders and reflects their requirements. Supports Product Managers on the refinement of features. Product Delivery: Leads and influences one or more cross-functional agile delivery teams to execute, and delivers on, product requirements. Works closely with the delivery team on a day-to-day basis, to action features/user stories. Participates and plays a lead role in SAFe ceremonies, scrum meetings, sprint demos, retros and product sprints with the delivery team. Represents the voice of the customer at the delivery team level by ensuring the product backlog items are visible and clear. Maintains metrics on the progress of the Team backlog and team deliverables. Monitors the quality of the deliverables by managing defects. Defines and refines the delivery roadmap and drives what goes into each release. Provides updates on project outcomes to clients or customers. Plays an active role in release activities, ensuring the relevant documentation is in place. Identifies, records and mitigates operational and technical risks on own initiative. Follows agreed standards and ensures all relevant documentation is maintained in accordance with relevant regulatory guidelines and SOP s ensuring all relevant stakeholders are updated. Follows and is a leading advocate of the standard Product Owner practices and processes, ensures adherence and support in the definition of these standards. Owns the delivery of the Functional Requirements Specification (FRS). Functional Leadership: Provides coaching and support to the Product Owners in the group to help them develop and refine skills. Guides and leads, from a functional basis, one or more Product Owners on specific projects by distributing work and supporting them during the end-to-end process. Leads by example and provides clear direction and guidance to other Product Owners and is accountable for performance. Relationship management: Engages and influences wide variety and level of stakeholders including senior management, making recommendations on initiatives. Engages with stakeholders and end-users to gather feedback, understands their needs, and relays this information to the delivery team. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Manages expectations of stakeholders on what is being delivered / released and what is not being delivered. Helps develop and enhance stakeholder relationships. Business analysis: Leads investigating operational requirements, problems, and opportunities, seeking effective business solutions through improvements in automated and non-automated components of new or changed processes. Leads the analysis of stakeholder objectives, and the underlying issues arising from investigations into business requirements and problems and assists in identifying options for consideration during the delivery process. Works iteratively with stakeholders, to identify potential benefits and available options for consideration, and in defining acceptance measures. User centricity analysis: Works closely with UX Design to ensure mock-ups are ready on time and accurately reflect expected product design. Evaluates prototypes or designs of systems, products or services against agreed usability and accessibility expectations. Interprets and presents results of evaluations and priorities issues. Works with Product Managers to detail user journeys (AS IS and TO BE) and user activities to better determine baseline metrics and identify where improvements/efficiencies can be made. Business process improvement Analyses and designs business processes, identifies alternative solutions to exploit new technologies and automation. Develops graphical representations of business processes to facilitate understanding and decision making. Analyses and designs the assessment for feasibility of business process changes and recommends new approaches. Implements business process improvement methods and tools at program, project and team level in line with agreed standards. Data Analysis (if required): Leverages data analysis to extract meaningful insights, enabling informed and data-driven decision-making. Develops models and diagrams to represent and communicate data requirements and data assets. Other: Carryout any other reasonable duties as requested. Functional Competencies (Technical knowledge/Skills): A strong understanding of SDLC and related technologies is necessary. Detailed knowledge of medical imaging domain area including modalities, equipment, Imaging endpoints, read criteria and viewers in the relevant Service Lines. Understanding of Agile methodologies (preferably Scrum and SAFe, UML, and orientated, Data Modelling using appropriate industry standards and/or other BA methodologies). Demonstrable knowledge of Lean Six Sigma. Demonstrable knowledge of Root Cause Analysis. Demonstrable knowledge of risk identification, analysis and mitigation. Excellent interpersonal, verbal and written communication skills. A flexible attitude concerning work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. Ability to work methodically in a fast-paced, time-sensitive environment. Displays a product mindset with strategic and user-centric thinking. Demonstrable ability to apply critical thinking to solve problems and tasks. Shows initiative and self-confidence, is adaptable and can cope with changing and evolving priorities. Ability to identify and implement process improvements. Proactively participates in skills improvement training and encourages their teams to participate. A self-starter and able to work under own initiative with ability to define owns path and drives work forward with little guidance or supervision. Adapts to new environments with little guidance. Good confident presenter to peers and stakeholders, including senior management. Maintains an up-to-date awareness of trends, tools, technology, techniques, and processes that affect technology within the Life sciences domain. Natural coach who leads by example with an approachable demeanor. Experience, Education, and Certifications: Solid professional experience as a Product Owner or in a very similar role. Experience in coaching and training colleagues and peers. Experience of working in and knowledge of medical imaging in clinical trials within the life sciences sector Demonstrable experience of regulated environments. Experience with product lifecycle management tools. Experience in process Modelling using standards such as BPMN. Experience in Scope Management. Bachelors Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience. English: Fluent. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Project Role: Senior Business Analyst Total Experience: 5 to 7 years Work location: Bangalore , Pune & Mumbai Mode : Hybrid Education: Bachelor's Degree Computer Science or Life Sciences, or equivalent experience Job Overview: Under general supervision, provides systems support in developing and enhancing business systems to provide new or enhanced products to clients or effective planning, reporting, and analysis tools to internal functions. Roles & Responsibilities: Formulates and defines systems scope and objectives through research and fact-finding combined with an understanding of applicable business systems and requirements Develops or modifies moderately complex information systems Includes analysis of business and user needs, documenting requirements, and revising existing system logic difficulties as necessary. Guides and advises less-experienced Business Systems Analysts. Competent to work in some phases of systems analysis and considers the business implications of the application of technology to the current business environment. Is able to understand and analyze Lab Data - to then present back to stakeholders Will use PowerBI to create functional working product prototypes to aid solutioning and requirements elicitation Querying Systems Data using SQL Will coordinate and drive a Project from concept through to finalization, under general supervision Skills & Abilities: Six (6) years experience in IT within a Lab setting. Preferable: Three (3) years experience as a Business Analyst within Lab/Clinical Trials setting Knowledge of business-wide applications (e.g. third party software internal operational applications, etc.) or IQVIA client facing applications and products Demonstrated ability to understand client requirements and as well as underlying infrastructure applications, systems and processes to enable execution of those skills. Thorough knowledge of IQVIA data and current systems. Ability to query data using SQL Knowledge and ability to use PowerBI to effectively present analytical data

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Are you looking to join a company where your contributions truly matter, and where youll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn . Job Description Participates in protocol review with clients, provides suggestions regarding ability to capture protocol information in database successfully Contribute to study tracking and metric reports for use by the study team Contribute to CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits Contribute to user acceptance testing (UAT) of EDC and integrated systems including executing of test plan and scripts. Assist with preparation for training sites/users training on EDC applications, and UAT. End user knowledge for study conduct activities including queries management, standard reporting and extracting data in multiple EDC systems. Independently develops data entry screens, dynamics, edit checks and other EDC components in multiple EDC systems. Ability to program using SQL, SAS or another programming language. Provides input to resolve issues in data management study processing activities Develops appropriate study documentation Develops the clinical trial databases, data entry screens and edit checks. Completes and oversees execution of user acceptance testing (UAT) of study-specific systems and applications Interacts with cross-functional team members to ensure completion of all timelines and studies Develops requirements and/or programs data listing and data edits as appropriate Assumes responsibility for quality and integrity of clinical database creation Trains sites/ users on EDC system and applications as appropriate Proposes and implements solutions to client issues where necessary Conducts thorough self-review of deliverables prior to release to client; serves as high level reviewer for others. Ensures compliance to applicable ISMS policies and procedures Complies with Record Control Procedure Job Requirements Atleast 5 years experience with Clinical Database programming Strong management and Rave Study Build skills Expert Custom Function programming is mandatory College graduate in computer science or related discipline, or related experience Strong knowledge of drug development as it pertains to data management Hands-on experience with clinical trials and pharmaceutical development process Experience in pharmaceutical or CRO industry Knowledge of clinical database structures Knowledge of CDISC/CDASH data standards and their application to CRF and database design Proficiency with MS Office applications Excellent organizational and communication skills Familiarity with ISO 9001:2008 requirements

Are you seeking a purposeful and rewarding commercial RFI & Content career opportunity within the Clinical Research industry? Our operations in India are growing, and with big ambitions and a clear vision for the future, now is the time to join Clario s global team as an RFI & Content Analyst. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing RFI/RFQ Management Process RFI/RFQ requests through the Clario proposal response system, including but not limited to, site and device qualification forms Review responses suggested by the system for relevancy and update where necessary Investigate technical specification documentation, user manuals etc. to obtain information as required Liaise with internal SMEs to obtain information as required Ensure the timely and accurate delivery of all deliverables Database Management Management of the RFI content library Maintain accuracy of responses in the RFI content library Manage RFI/RFQ requests in Salesforce Manage the systematic SME review of stock answers through the system Manage library of SME responses within the system Internal Relationship Management Manage interactions with SMEs relating to detail gathering for RFI/RFQ through the system Manage communication, updates and expectations of Project Management and other internal requestors as required Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Supporting other functional teams with any information request needs Perform other duties as assigned What we look for Bachelor s degree, or minimum years experience required as outlined below Knowledge of Salesforce or similar CRM tool required Microsoft Office applications including Excel, Word and Access required RFI/RFQs and/or content management tools experience desirable 2+ years experience in Project or Proposal Management/Co-ordination, Relationship Management/Account Management, liaising with multi-departmental stakeholders 2+ years relevant industry experience preferred Ability to work independently or in team setting; ability to adjust to changing priorities Excellent attention and orientation toward meticulous work Strong organization skills and ability to prioritize and meet deadlines Strong interpersonal and communication skills, both verbal and written Ability to project and maintain a professional and positive attitude . EEO Statement .

MAIN PURPOSE OF ROLE Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Medical Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES As the Experienced professional in the Medical Affairs Sub-Function, possesses well developed skills in overseeing the direction, planning, execution, clinical trials/research and the data collection activities. Contributes to implementation of clinical protocols, and facilitates completion of final reports. Recruits clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases III & IV for company products under development. Participates in adverse event reporting and safety responsibilities monitoring. Coordinates and provides reporting information for reports submitted to the regulatory agencies. Monitors adherence to protocols and determines study completion. Coordinates and oversees investigator initiations and group studies. May participate in adverse event reporting and safety responsibilities monitoring. May act as consultant/liaison with other corporations when working under licensing agreements. QUALIFICATIONS Education Associates Degree ( 13 years) Experience/Background Minimum 1 year JOB FAMILY: Medical & Scientific Affairs LOCATION: India > Kolkata : Garg House, 11, A/1D t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Drug Safety Physician (Gurgaon: On-site) - DDReg pharma Job purpose To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection, risk management, and pharmacovigilance oversight for assigned projects. Duties and responsibilities Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs. Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks. Communicating safety information to regulatory agencies, healthcare professionals, and the general public. Collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed. Participating in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs. Reviewing and approving of protocol for clinical trial safety and contributing to the report of clinical trial safety. Staying up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards. Reviewing and evaluating the safety and efficacy of new drug candidates during the development and approval process. Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately. Collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders. Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs. Providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients. Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market. Being responsible for the overall safety of the drug, from preclinical development to post-approval. Education & Experience Bachelor s or Master s degree in Medical or Dental Sciences Previous experience that provides the knowledge, skills, and abilities to perform the job (3+ years ). Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong understanding of Medical Sciences Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Apply Online First Name Last Name A valid email address is required. 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Fortis Hospital Mohali is hiring for Head Clinical Pharmacology interested candidates can share profile at baljinder.singh@fortishealthcare.com

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships. Description: At least 7-18 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs) Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. Experience in applying AI in standardization, SDTM, ADaM and TFL generation. Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM Experience in innovative ways to automate testing and validation Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI) Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity. Masters degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

We are seeking a skilled Business Analyst with experience in healthcare and life sciences to translate complex domain requirements into clear functional specifications. The role focuses on supporting product development initiatives by aligning business needs with technical solutions across the PDLC. Requirement Gathering & Analysis Business Analyst Product Development Lifecycle (PDLC) Pharmacovigilance (PV) ICSR IQVIA Vigilance Platform Clinical Trials Regulatory Affairs Medical Affairs Risk-Based Quality Management Veeva CTMS Safety Intelligence CluePoint Signal Oversight Labeling Management Product Traceability Randomization

About PhonePe PhonePe is India's largest transactions platform built on payments. It is the crusader of UPI payments and a proud contributor to the hypergrowth of the world's most advanced payments system. PhonePe started in 2015 and has achieved many milestones in the last 6 years and is rightly India's Payments App. Culturally, as a team, we learn fast, fail fast, act to impact, run lean and collaborate to bring out excellence and intellectual honesty in each other. Skills Expected: Solid foundational knowledge of information security principles and Governance, Risk, and Compliance (GRC). Exceptional communication abilities, both spoken and written. Effectively manage and engage stakeholders. Team & Responsibilities: As part of the IT Compliance team, you will collaborate with various stakeholders to ensure our products are developed in accordance with regulatory requirements. Given PhonePe's diverse licenses (Wallet, e-KYC, UPI, etc.), you will play a key role in supporting multiple compliance audits. Additionally, you will be involved in our Third-Party Risk Management program, conducting risk assessments on vendors in partnership with business teams and the vendors themselves.Day-to-Day (BAU):Your responsibilities will include interpreting regulations to align with PhonePe's business operations and identifying and gathering necessary evidence to demonstrate ongoing regulatory compliance. PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles) Insurance Benefits - Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance Wellness Program - Employee Assistance Program, Onsite Medical Center, Emergency Support System Parental Support - Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Higher Education Assistance, Car Lease, Salary Advance Policy