TMF Inspection Readiness Specialist

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.