Job Description
Are you ready to shape the future of medicine? Catalyst Therapeutics is seeking a highly skilled Clinical Data Manager to join our dynamic team in Boston, Massachusetts. As a leader in biopharmaceutical research, we are dedicated to delivering breakthrough therapies that improve patient lives worldwide.
In this pivotal role, you will oversee the entire lifecycle of clinical data, ensuring accuracy, integrity, and compliance with global regulatory standards. You will collaborate with cross-functional teams to drive the development of our pipeline, utilizing cutting-edge technology to streamline clinical trials.
Why Join Catalyst Therapeutics?
- Impactful Work: Contribute to life-changing therapies.
- Innovation: Work with state-of-the-art data management systems.
- Competitive Benefits: Comprehensive health, dental, vision, and 401(k) matching.
Responsibilities
- Manage the end-to-end clinical data lifecycle, from source data verification to database locking.
- Ensure strict adherence to 21 CFR Part 11, GCP, and internal SOPs regarding data integrity.
- Lead the design, development, and validation of Electronic Data Capture (EDC) systems.
- Analyze clinical data using statistical software (SAS, R, or Python) to support medical writing and reporting.
- Collaborate with Clinical Operations, Medical Writing, and Statistical Programming teams to resolve data queries and discrepancies.
- Maintain and document Data Management plans and Data Validation strategies.
Qualifications
- Bachelor’s degree in Life Sciences, Statistics, Nursing, or a related field required; Master’s degree preferred.
- 3-5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Expert knowledge of CDISC standards (SDTM, ADaM) and regulatory submissions (e.g., NDA, IND).
- Proficiency in data management software (e.g., Rave, Oracle Clinical, REDCap) and statistical tools (SAS, R, Python).
- Strong understanding of Good Clinical Practice (GCP) and data privacy regulations.
- Excellent communication skills with the ability to present complex data concepts clearly.