Lead Clinical Data Manager
Lead Clinical Data Manager
Posted on :
14-07-2025
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1 Vacancy
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Job Description
Responsibilities:
- Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards.
- Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
- Develop and implement data management plans case report forms (CRFs) edit checks and data validation plans in alignment with study protocols and regulatory requirements.
- Oversee the design build and validation of clinical databases using Medidata Rave EDC ensuring optimal configuration and functionality.
- Conduct thorough reviews of clinical data identifying trends inconsistencies and potential issues that may impact data quality or study outcomes.
- Collaborate with cross-functional teams including Biostatistics Clinical Operations Safety and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
- Provide oversight and performance management of external data management vendors.
- Maintain SOPs guidelines and best practices for clinical data management processes.
- Represent the Clinical Data Management function in internal and external meetings providing expert guidance on data-related matters.
- Stay current with industry trends regulatory requirements and technological advancements in clinical data management particularly in the oncology field.
Requirements:
- Bachelors degree in Life Sciences Computer Science or a related field; advanced degree preferred.
- A minimum of 7 years of clinical data management experience in the biotechnology or pharmaceutical industry.
- Experience managing oncology clinical trials data including a deep understanding of oncology-specific data requirements and challenges.
- Expert-level proficiency with Medidata Rave EDC including system configuration form design and edit check programming.
- Strong knowledge of clinical research processes FDA & ICH guidelines GCP GCDMP and CDISC standards.
- Demonstrated experience in CRO and vendor oversight.
- Excellent project management skills with the ability to manage multiple studies simultaneously.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Outstanding communication and interpersonal skills with the ability to effectively collaborate with diverse stakeholders.
- Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g. SAS R) is a plus.
- CCDM (Certified Clinical Data Manager) certification.
- Experience with risk-based monitoring in oncology studies.
- Knowledge of emerging technologies in clinical data collection and management (e.g. ePRO wearables AI/ML applications).
Employment Type
Full-time
Key Skills
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