Data Lead for Performance

1 month ago


Maidenhead Berkshire, United Kingdom Fortrea Full time

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. This is an office-based role in Maidenhead.
Maintaining a paper TMFs in a state of audit readiness for quality and Fortcompliance.
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.

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.
¨ 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.
¨ Follow-up findings until resolution/CAPA implementation.
¨ Monitor project scope and communicate any identified out-of-scope activity or requests to the Project Lead.
¨ Responds to any CAPAs issued on guidance with the Management Team.
¨ Responsible for monitoring completeness of the study TMF at each Milestone Review. 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.
¨ alerts management of trends as applicable
¨ Review and respond to TMF content quality issues
¨ Maintains an understanding of applicable regulatory requirements
¨ Contributes to business development opportunities
¨ Helps in drafting the job aids and WI if any
¨ Helps in Migration if any
¨ 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. 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. For more information about how we collect and store your personal data, please see our Privacy Statement . #



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