Orano Med Theranostics
Are you passionate about ensuring the highest standards in pharmaceutical manufacturing? Do you thrive in a fast-paced, detail-oriented environment where your work directly impacts clinical trial success?
Join our Records Management team as a Senior Manager, Records Management and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Are you seeking your next challenge as Senior Manager, Records Management, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out.
The (Sr.) Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform.
Key Responsibilities
Responsible for developing and implementing a comprehensive records management strategy that is GCP and GDP compliant including oversight and archival SOPs and set-up and management of a TMF archival platform.
Select and onboard/implement a TMF platform.
Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings.
Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible.
Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections).
Stay current with regulatory requirements and industry best practices related to records management and TMF.
Education & Experience
- Bachelor’s degree in Life Sciences, Information Management, or a related field; advanced degree preferred.
- Minimum of 5-7 years of progressive experience in records management within the pharmaceutical or biotech industry.
- Proven experience in setting up and managing TMF for clinical studies.
- Experience with implementing electronic records management systems and software.
- Demonstrated knowledge of regulatory requirements and industry best practices for records management in clinical research.
Required Skills & Competencies
- In-depth knowledge of records management principles and practices, particularly in the context of clinical trials and pharmaceutical research, including the ability to recommend where documents should be filed.
- Familiarity with regulatory requirements related to clinical documentation, including GCP, GDP, FDA, EMA and ICH guidelines.
- Strong organizational skills and attention to detail.
- Ability to manage and organize complex data sets and use critical thinking to identify issues.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively with cross-functional teams.
- Proficiency in electronic document management systems (EDMS) and other relevant software.
- Strong problem-solving skills and the ability to develop and implement effective solutions.
- Ability to manage multiple priorities.
Preferred Skills & Competencies
- Experience in a startup environment is a plus.
