TMF Lead II

Manages and supports the study TMF right from the study set up to the closeout, including the transfer of the TMF. Managing study TMF health and completeness. Responsible for initiating the Review workflow.

Summary of Responsibilities:

• The position provides process, control, coordination, and approval of clinical trial documents.
• The position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
• Is the primary TMF Delivery Center point person for assigned studies.
• Conduct TMF-specific Kick-off Meeting with Sponsor and Fortrea project team to establish expectations, requirements and deliverables in line with ICH and to support scope build.
• Oversees the planning, set-up, maintenance, QC, and closure of the study TMF for clinical studies, in accordance with agreed TMF processes (Fortrea or sponsor SOPs) working with key study personnel as identified.
• Confirms internal and external system access needs.
• Accountable for the creation and maintenance of the TMF Plan and TMF Index in collaboration with the Project Manager/Project Lead and Sponsor.
• Maintenance of access within the TMF system in collaboration with the TMF access management team.
• Compliance with current Fortrea eTMF system training requirements. Where needed, complete required eTMF system training for sponsor systems.
• Provide project team training on study specific TMF plan and Index or other Trainings, as required.
• Ensure deviations from standard Fortrea TMF business process and operating model are documented accordingly in TMF Plan or other applicable document.
• Document and escalate all identified compliance issues. Follow-up findings until resolution/CAPA implementation.
• Monitor project scope and communicate any identified out-of-scope activity or requests to the Project Lead.
• Receive sponsor-specific report requests (confirm required, within scope). Work with appropriate TMF operational services and TMF system experts to evaluate the feasibility of sponsor-specific report requests and ensure development and delivery as appropriate.
• 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 requiredness and count, in collaboration with leads from each functional group within the study.
• Ensure ongoing "real-time" EDL maintenance updates are maintained by each functional group per assigned study.
• Oversee timely kick-off of TMF Review Workflows on or before 25th Day of the Milestone Release.
• Responsible for monitoring completeness of the study TMF at each Milestone Review.
• Escalates missing, incomplete, incorrect, inaccurate artifacts to the appropriate study team members. Setting up a monthly meeting with the Study Team.
• Oversee the processing of essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs (as applicable), GCP, and ICH guidelines.
• Leads Project Review/Governance debrief and set up meetings on the same.
• 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.
• Review and respond to TMF content quality issues.
• Assists the TMF Remediation team as and when required for assigned studies.
• Attend and/or present at internal or external study team meetings as required.
• Maintain 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.
• Act as the Point of Contact for Technical Issues faced by other TMF DC roles (eg: Classifiers, Reviewers) during maintenance of the TMF in the UCV system.
• Manage 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.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelor s Degree with a Life Sciences/Business focus.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Excellent interpersonal skills.

Experience (Minimum Required):

• Minimum 11-13 years experience working in a clinical research environment.
• 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.

Preferred Qualifications Include:

• Masters s Degree with a Life Sciences/Business focus.
• Equivalent experience within clinical research environment of a minimum of 11-13 years, may be substituted for education requirements.
• Experience working in clinical electronic systems preferred.

Physical Demands/Work Environment:

• Office working conditions.
• Minimal (less than 10%) as required for Sponsor Kick-Off Meetings, Face to Face Client Meetings, when requested.
• Travel is primarily to within home region and/or other Fortrea locations