Senior Manager, TMF Operations (eTMF / Veeva Vault)
About The Position
The Senior Manager of Clinical Standards & Processes (CS&P) will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work (vendor and/or CRO) and performing oversight to TMF metrics and trends. In addition, the Senior Manager of CS&P may be tasked with projects that ensure proper framework of TMF related processes and ongoing compliance to Standard Operating Procedure/ Work Instruction (SOP/WI) and Good Clinical Practice (GCP)/Good Documentation Practice (GDP). The primary purpose of the position is to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations.
Requirements
- Minimum of 8 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 2 years in a managerial or lead role/ minimum of 3 years in TMF experience (preferred).
- Minimum 2 years Veeva eTMF experience in a management role.
- Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
- Experience in inspection
- Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (eTMFs).
Nice To Haves
- Bachelor’s degree in a Science discipline
- Knowledge of industry compliance trends
- Proficient in Smartsheets
Responsibilities
- Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable.
- Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, and company processes.
- Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management
- Assist Associate Director with eTMF system administration functions (CS&P is the business owner of the eTMF system).
- Manage eTMF and Study TMF training for internal and external user access.
- Oversee CS&P role in eTMF user access process in accordance with applicable SOP/WI and escalate issues as required to Senior Management
- Direct junior CS&P staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study
- Oversee clinical vendor management and escalate issues as required to Senior
- Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during
- Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable.
- Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as
- Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls).
- Ensure consistency and standardization of processes across Clinical Operations.
- Collaborate with other cross functional areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational
- Support the Associate Director of CS&P and Clinical Operation Senior Management in leading various process improvement initiatives.
- May manage direct reports.
Benefits
- Arrowhead provides competitive salaries and an excellent benefit package.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
