- Maintenance of a paper Trial Master File (TMF) in accordance with applicable SOPs and ICH-GCP guidelines, and study-specific TMF Index.
- Maintaining a paper TMFs in a state of audit readiness for quality and Fortcompliance.
- Reviews TMF documents according to the ALCOA+ principles.
- Processes (print, code and file) final documents required throughout all phases of the study.
- Raises queries to the project team in case a document issue is detected and follow up until query resolution.
- Resolving QC issues raised by the project team during project team QC, if applicable.
- Working with key study personnel such as the Project Manager or Clinical Study Lead to resolve any filing issues.
- Prepares the paper TMF for QA or client audits & inspections, as well as project team or Sponsor physical paper TMF QCs.
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 & 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 & 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:
o Completing the Initial matching of Index with Expected Document List (EDL) update for requiredness & count, in collaboration with leads from each functional group within the study
o 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 (e.g.: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 other related duties as assigned
̈ Performs training and mentoring as required
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement. -
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TMF Lead II - Maidenhead, United Kingdom - Fortrea
Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.We are looking for an experienced TMF specialist for our TMF Lead II position. This is an office-based role in Maidenhead.
Will initially mainly support paper TMF tasks, as required:
Key Responsibilities:
