Manager, Clinical Records Management
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Conducts periodic quality reviews of study Trial Master Files to ensure quality, completeness and timeliness.
- Provides central records support across at the study level, including Operational Study Team cross-functional team members, study sites, CROs and other vendors.
- Draft documents/plans for clinical records management in line with GCP and regulations.
- Provides input into study essential records set-up, maintenance, and completeness for inspection readiness, providing records for inspection, as necessary.
- Supports migration and/or transfer of essential records from vendors (sites as necessary) in collaboration with cross-functional team members for final indexing and long-term archive.
- Supports implementation, maintenance and decommissioning of central records systems when applicable.
- Works in collaboration with cross-functions, Operational Study Team, CROs and other vendors on quality and compliance activities related to essential records in identifying and mitigating risk to clinical program.
Requirements
- Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field.
- Minimum 6 – 8 years (w/o Master’s) or 4 – 6 years (with Master’s) of relevant experience in biotech or pharmaceutical industry.
- Demonstrated understanding of Trial Master File structure and TMF systems.
- Experienced in problem-solving.
- Ability to collaborate with cross functional teams in document compliance.
- Experience in relevant regulatory requirements.
- Experience working with vendors.
- Able to assist in implementation of process improvements.
Benefits
- Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
- Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Trial Master FileTMF systemsclinical records managementregulatory requirementsdocument complianceprocess improvements
Soft skills
problem-solvingcollaborationcross-functional teamwork
Certifications
Bachelor's degreeadvanced degree