TMF Inspection Readiness Specialist

A TMF (Trial Master File) Inspection Readiness Specialist acts as a steward for the TMF and has advanced knowledge on PAREXEL or Sponsor specific Electronic Trial Master File (eTMF) and paper documents management processes and procedures. The TMF IR Specialist represents a primary Point of Contact for the study TMF.The TMF IR Specialist assumes the ability to coordinate study TMF activities with a high degree of proficiency, focusing on TMF Inspection Readiness. Achieves department’s overall business objectives and works with all relevant stakeholders, providing TMF expertise and facilitating adequate oversight.

- Participates in study kick-off meeting and drives discussions regarding design of TMF plan.- Provides recommendations in terms of and client expectations for TMF, including budget and resources implications.- Works with the PL to set realistic client expectations and enable client TMF oversight.

- Coordinates TMF milestones in collaboration with the TMF reviewer and/or other TMF contracted tasks according to the established timelines and quality criteria.- Provides input to relevant project guidelines as required.- Proactively flags potential project risks in terms of TMF deliverables and provides feedback to project team and client to design solutions.- Leads or participates in internal monthly TMF review meetings, regularly providing TMF status updates.- Provides TMF expertise to manage client concerns in terms of TMF.

- Identifies inconsistencies and inefficiencies in processes and recommends solutions.- Recognizes out of scope activities and communicates to responsible Project or Functional Leader.- Assesses required resources against study QC plan / study TMF milestones, study budget/hours and other key factors directly impacting TMF QC plan / milestone reviews, where applicable.- Provides feed-back to PS/FL Super Users in CRS Technology in order to enable enhanced systems, tools and processes.- Maintains proactive communication and collaboration with Clients

- Monitors and evaluates TMF Inspection Readiness status, employing available tools and metrics, escalating concerns and proposing action items to the study team if needed- Maintains the TMF for ongoing studies according to Parexel SOP’s or contractual obligation to sponsor; if required may perform completeness checks/ milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria.

- Takes proactive measures to prepare studies for audit and inspection preparation.- Attends audits and inspections as TMF representative

- Manages TMF tools customization and TMF Plan / CFMP development, updates and sign off

- Fully able to deliver training and mentoring for junior team members.- Identifies best practices developed during project and shares lessons learned across the organization or at project level, as applicable.- Proactively flags re-training needs for study team on general or study specific TMF requirements.

- Collaborates with Project Leader and the other Functional Leads to confirm TMF activities are completed at study close out as required by Sponsor and Parexel procedures.