- Care deeply about your work and its impact on people
- Are an excellent communicator who values transparency
- Collaborate well, working across organizational boundaries
- Are committed to getting things done
- Have character, honesty and integrity
If that describes you, please reach out to email@example.com for our current opportunities.
We currently have an opening for: Clinical Document Control Specialist
This position is responsible for the maintenance and quality oversight of all records systems for the Clinical Development programs in conjunction with best practices, GXP, and corporate policies.
- Review, organize and maintain all study compliance documentation
- In-Depth review and ensure completeness and accuracy of eTMF
- Review Country level eTMF (e.g. country submissions, approvals)
- Review Study level eTMF (e.g. protocol and all amendments, IBs, INDSRs, vendor files……etc.)
- Review Site Level eTMF (e.g. 1572s, CVs, IFDFs, IRB documentation, local lab documentation, IP supplies, SUSAR AoRs, etc.)
Requires at least 2 years of work experience in the document control management, preferably in clinical research or 2+ years of Biotech/Pharmaceutical CRA experience. Prefer candidates with 5 or more years of relevant experience.
We offer a competitive compensation and benefits package as well as an environment where your contributions can make a significant difference. To apply, please email us at: firstname.lastname@example.org