TMF Lead II - FSP - US

About the role

The TMF Management team is seeking a TMF Lead II to manage and support the study Trial Master File (TMF) for all sponsored studies. This role is responsible for ensuring the completeness and accuracy of the TMF and driving inspection readiness efforts.

Responsibilities

• Manages and supports the study TMF right from the study set up to the closeout, including the transfer of the TMF.
• Maintains and assesses the overall TMF health (quality, completeness, and timeliness).
• Provides technical expertise on the electronic TMF (eTMF) and supports Inspection Readiness goals in compliance with ICH/GCP guidelines.
• Manages process, control, coordination, and approval of clinical trial documents.
• Oversees the planning, set-up, maintenance, quality control (QC), and closure of the study TMF for clinical studies.
• Monitors and escalates missing, incomplete, incorrect, or inaccurate artifacts to the appropriate study team members.
• Ensures ongoing "real-time" EDL maintenance updates are maintained by each functional group per assigned study.
• Oversees the preparation of the TMF for QA or Sponsor Audits and Inspections and participates in Audit and Inspections as required.
• Responds to any CAPAs issued on guidance with the Management Team.
• Maintains the TMF in a state of audit/inspection readiness by completing the Initial matching of Index with Expected Document List (EDL) update for required documents and count.
• Reports on Portfolio and Study Level Key Performance Indicators (KPIs) as applicable, monitors study metric compliance, and provides remediation guidance as required.
• Identifies trends per study and across programs; alerts management of trends as applicable.
• Reviews and responds to TMF content quality issues.
• Assists the TMF Remediation team as and when required for assigned studies.
• Attends and/or presents at internal or external study team meetings as required.
• Maintains awareness of study events and the associated documentation requirements.
• Maintains effective internal and external communication.
• Collaborates with all members of TMF Operational Services.
• Contributes overall client satisfaction.
• Maintains an understanding of applicable regulatory requirements.
• Contributes to business development opportunities.
• Acts as the Point of Contact for Technical Issues faced by other TMF DC roles (e.g.: Classifiers, Reviewers) during maintenance of the TMF in the UCV system.
• Manages complex and large studies.
• Helps in drafting the job aids and WI if any.
• Helps in Migration if any.
• Performs training and mentoring as required.

Qualifications

• BS/BA degree in related discipline and a minimum of six-seven years of related experience; or, MS/MA degree in related discipline and a minimum of three years of related experience; or, Equivalent combination of education and experience.
• Minimum 7 years’ experience working in a clinical research environment.
• 5+ years experience in TMF.
• Clear understanding of GCP and ICH guidelines.
• Knowledge of Regulatory/Clinical document requirements.
• Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.