Tmf Lead I

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.
Type: Full-Time, Office-Based Role - Maidenhead | Contract: Fixed Term
Join us as a TMF Lead, overseeing the meticulous maintenance of paper Trial Master Files (TMFs) in compliance with SOPs and ICH-GCP guidelines. Your role involves ensuring audit readiness, reviewing documents, addressing issues, and collaborating with project teams to resolve filing challenges. If you're detail-oriented and experienced in clinical trial documentation, apply now to be a crucial part of our dynamic team.
Key Responsibilities:

• 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 compliance.
• 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.

Other responsibilities:

• 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.
• Performs other related duties as assigned.

Education / Experience:

• Minimum 2 years’ experience working in a clinical research environment.
• Clear understanding of GCP and ICH guidelines.
• Knowledge of Regulatory/Clinical document requirements.
• Experience working in clinical electronic systems preferred.
• Excellent interpersonal skills.

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 www.fortrea.com.
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.
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