What are the responsibilities and job description for the Clinical Data Management Lead position at Daiichi Sankyo?
Job Description
The Clinical Data Management Lead is responsible for ensuring the accurate and timely delivery of medical coding services for assigned programs. This role requires a strong understanding of medical terminology and industry standards, as well as technical skills in coding data received from CROs and vendors. The ideal candidate will have experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections.
Responsibilities
Requirements
The Clinical Data Management Lead is responsible for ensuring the accurate and timely delivery of medical coding services for assigned programs. This role requires a strong understanding of medical terminology and industry standards, as well as technical skills in coding data received from CROs and vendors. The ideal candidate will have experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections.
Responsibilities
- Responsible for medical coding completion and resolution of all coding-related queries prior to database lock.
- Conducts final coding listings review; distributes final coding listings for medical review and approval.
- Drafts the final coding approval form and coordinates approval.
Requirements
- Bachelor's Degree required.
- 4 years of clinical data management medical coding experience in a medical device, pharmaceutical company, or similar environment.
- Certified MedDRA Coder (CMC) or equivalent preferred.
