Job Description
Are you a visionary data expert looking to drive breakthroughs in life sciences? Apex BioPharma Solutions is seeking a highly skilled Senior Clinical Data Manager to join our elite team in Boston. In this pivotal role, you will oversee the integrity and quality of clinical trial data, ensuring compliance with global regulatory standards and accelerating the path to market for life-changing therapies. We offer a competitive benefits package, a dynamic work environment, and the opportunity to work on cutting-edge pharmaceutical projects.
Why Join Apex BioPharma?
* Work with a world-class team dedicated to improving global health outcomes.
* Access to continuous learning opportunities and professional development.
* Competitive compensation and comprehensive health benefits.
* State-of-the-art facilities in the heart of Boston's biotech corridor.
Responsibilities
- Lead the end-to-end clinical data management lifecycle, from source data verification to database lock, ensuring accuracy and timeliness.
- Oversee data cleaning, validation, and reconciliation processes to meet FDA, EMA, and ICH GCP guidelines.
- Manage and mentor a team of junior data managers, fostering a culture of quality and continuous improvement.
- Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Medical Writing to resolve data issues efficiently.
- Implement and maintain advanced data management systems, including R, SAS, and SQL.
- Prepare and review data management deliverables, including Data Management Plans (DMPs) and CRF designs.
Qualifications
- Master’s degree in Life Sciences, Health Informatics, Biostatistics, or related field required; PhD preferred.
- Minimum of 5-7 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry.
- Expert proficiency in programming languages such as R, SAS, or SQL for data manipulation and analysis.
- Strong working knowledge of CDISC standards (SDTM, ADaM) and data validation methodologies.
- Valid Certified Clinical Data Manager (CCDM) or equivalent certification is highly desirable.
- Excellent communication skills, with the ability to articulate complex data issues to non-technical stakeholders.