ATTENTION Boston/Cambridge, Massachusetts area ONLYThe Professional Services team at Cencora Pharmalex are a diverse set of individuals with unique expertise and experience, offering Study Resources, Study Services and Consulting Services to customers. The services are designed to work independently as well as collaboratively, fitting the customer’s needs and budget.
Purpose The TMF Study Owner provides pivotal support and subject matter expertise (SME) at a study level, proactively ensuring our clients’ Trial Master Files (TMFs) are achieving an inspection ready state. They are an integral part of the study team, becoming a single point of contact to help maintain TMF health, consistency, and compliance across clinical trials within the organization.
This is a fully remote role with working hours expected to match the requirements of the customer’s business day. Travel is not an expectation of the role, however occasional travel may be required depending on customer requirements, for example in the case of an inspection or to complete paper TMF activities.
Key Activities Document Management & Quality
- Remain familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices.
TMF Management
- Support the setup of the study-specific TMF structure, liaising with the Study Team to establish requirements.
- Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented.
- Monitor milestones and events to ensure TMF Completeness via eTMF functionality.
- Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team.
- Support study team through closeout and archive preparations.
- Ensure ongoing adherence to TMF SOPs and specifications.
- Create study-specific TMF Index (or equivalent).
TMF Health & Metrics
- Perform and/or support QR and perform spot-checks for quality oversight.
- Provide TMF Health status updates and review metric reports outputs with the study team on a recurring basis, including verbal and/or written summaries.
- Help facilitate, track, and support periodic Study Team TMF Reviews.
- Maintain TMF Health oversight over study lifecycle.
- Provide guidance on how to improve and maintain TMF Health.
- Review metric report outputs with Study Teams on a recurring basis.
- Perform a deep-dive of report outputs; identify and share trends and risk areas with Study Teams.
- Provide guidance on how to improve and maintain metrics.
Inspection Readiness
- Manage remediation and retrospective reconciliation projects.
- Manage inspection preparation.
- Support audits and inspections.
- Support implementation of CAPAs at study level.
- Identify and escalate risk and trends impacting Inspection Readiness.
Customer Relationships
- Facilitate TMF-focussed communication and collaboration between Sponsor and CROs.
- Communicate to the Study Manager (or equivalent) on all aspects of the TMF.
- Build proactive relationships with study teams, providing continued SME support.
- Understand and utilise appropriate escalation pathways.
Policies & Procedures
- Provide feedback on processes relating to TMF Management.
Training & Mentoring
- Act as TMF SME, including related processes, to provide ongoing support to Study Team.
- Provide feedback to support development of internal and/or external TMF-related trainings.
- Conduct training for Study Team and/or colleagues, either 121 or in group setting.
Minimum Required Skills & Experience Technical Expertise - 5 years relevant industry experience in Clinical or TMF Operations oversight.
Excellent knowledge of:
- Good Documentation Practices (GDP)
- Document recognition
Good knowledge of:
- Referencing/Applying applicable resources
Working knowledge of:
- Clinical trial lifecycle
- TMF Reference Model (or equivalent)
- eTMF systems
- TMF Health & Metrics, including Quality Review process
- Internal communication/escalation pathways
Familiar with:
- TMF lifecycle
- Other clinical/document management systems
- TMF stakeholders
- End to end tasks, including TMF set-up process and Management Plans
- TMF training
- Inspection Readiness
- External communication/escalation pathways
Soft Skill Expertise Proficient in:
- Verbal and written communication
Independent in:
- Internal collaboration
- Interpersonal interactions
- Organization
- Prioritization
Experienced in:
- Coaching & mentoring
- Presenting information
Developing in:
- External collaboration and negotiation/conflict resolution
- Working under pressure and Information Analysis
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
