We are looking for a Senior Lead Clinical data manager with over 5 years of lead experience for a late-stage biopharmaceutical in MA. This is a contract to perm role. Recent oncology and phase III experience is a must!
No Corp 2 Corp candidates please. W2 only
Description:
- Acts as the main point of contact for designated studies, participating in project teams and collaborating with CROs to oversee data management activities specific to each study.
- Coordinates and oversees clinical data management activities for designated studies, ensuring adherence to company SOPs, policies, and practices. This includes monitoring the data clean-up process conducted by CROs from study initiation through data archiving.
- Coordinates various activities such as medical coding, data validation checks, and database snapshots.
- Prepares and disseminates project status reports to the project team and management.
- Acts as the team leader for the Data Management (DM) department, ensuring databases are validated and prepared for transfer and/or analysis in accordance with company SOPs.
- Creates and maintains project documentation, including the Data Management Manual, CRF Completion Guidelines, validation specifications, and work instructions for assigned projects. Designs and updates CRFs as needed.
- Responsible for initiating and approving the construction, testing, and validation of clinical databases, as well as overseeing subsequent changes and data validation activities within those databases.
Required :
Bachelor’s degree in Science or a related field, along with 7-10 years of clinical data management experience in the biotechnology or pharmaceutical industry.
Previous Immunology, Oncology experience highly preferred.
W2 only
Skills:
CRF, eCRF, EDC