The Trial Master File (TMF) Study Owner (SO) Lead provides managerial oversight of document management deliverables of assigned TMF Study Owners (SOs) and/or document processing staff (e.g., TMF Study Owner Associates, TMF Document Specialists). The TMF SO Lead:
- Is accountable to TMF Operations LT for delivery of TMF-related goals.
- Manages, trains, and mentors/coaches TMF SOs and/or document processing staff to ensure completeness, consistency, compliance of TMF for assigned clinical trials from study start to study close/submission.
- Serves as Subject Matter Expert for TMF process, systems and related tools.
- Is the primary point of issue escalation for assigned TMF SOs and/or document processing staff.
- Contributes to the implementation of new and revised TMF process standards and system upgrades/enhancements.
- Works closely with the TMF Operations Head and Leads formulating strategies and specifications to be implemented for all clinical trials and programs in scope (i.e., interventional).
- Creates, maintains and assumes accountability for a culture of high-customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
MedicalSkills Required
- Provide managerial oversight of TMF Study Owners and document processing staff.
- Manage, train, mentor, and coach TMF Study Owners and document processing staff to ensure completeness and compliance of TMF.
- Serve as Subject Matter Expert for TMF processes, systems, and related tools.
- Act as primary escalation point for assigned TMF Study Owners and document processing staff.
- Contribute to implementation of TMF process standards and system upgrades/enhancements.
- Collaborate with TMF Operations leadership to formulate strategies and specifications for clinical trials in scope.
- Create and maintain a culture of high customer service, transparency, and workload alignment across functions.
- Work on premise at assigned location.
What the Team is Saying
Pfizer Compensation & Benefits Highlights
-
Healthcare Strength — Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
-
Retirement Support — A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
-
Leave & Time Off Breadth — Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.
Pfizer Insights
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
Gallery
Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
