Lead Clinical Data Manager
Remote/Work-from-Home Position
Must reside in Massachusetts
A fast-growing biopharmaceutical company that develops innovative targeted protein degradation therapies to treat a range of serious diseases is seeking a talented and experienced Lead Clinical Data Manager to join their team.
In this pivotal role, you will be responsible for overseeing the clinical data management function, including leading a team of clinical data managers. You will develop and implement data management strategies to ensure the integrity and quality of clinical trial data, collaborate with cross-functional teams, and drive the efficient collection, cleaning, and validation of clinical data.
Key Responsibilities:
- Manage the clinical data collection and cleaning processes, ensuring adherence to standard operating procedures and regulatory requirements
- Develop and oversee the implementation of data management plans for clinical trials
- Lead a team of clinical data managers, providing guidance, mentorship, and performance feedback
- Collaborate with clinical, regulatory, and biostatistics teams to define data requirements and ensure seamless data flow
- Implement data validation and quality control measures to identify and resolve data discrepancies
- Prepare clinical data for analysis and reporting, working closely with the biostatistics team
- Stay up-to-date with industry trends, regulations, and best practices in clinical data management
Qualifications:
- Minimum 5 years of experience as a Clinical Data Manager in the biopharmaceutical industry
- Strong understanding of clinical data management principles, processes, and tools
- Proficient in data management software and tools (e.g., CDMS, EDC systems)
- Excellent project management, problem-solving, and decision-making skills
- Proven ability to lead and mentor a team of clinical data professionals
- Preferred: Certification in clinical data management (e.g., CCDM, SCDM)
- Preferred: Bachelor's degree in a relevant field (e.g., life sciences, healthcare, informatics)