Job Overview:
Manages ARC review and is responsible for performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts and internal Fortrea business needs.
Summary of Responsibilities:
- Position provides process, control, coordination, and approval of clinical trial documents.
- Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
- Maintains an understanding of applicable regulatory requirements.
- Managing electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member.
- Responsible for performing TMF review. TMF Reviewers may include, but are not limited to, Project Team members, members of Global Quality Control and other reviewers (e.g. Central TMF Reviewers).
- Responsible for mapping the sponsors TMF Index with respect to Fortrea UCV and TMF Review, if applicable (TMF Reviewers).
- Maintains the TMF in a state of audit readiness for quality and compliance by:
- Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate.
- Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and Index, and study milestones.
- Comply with metrics established for performance TMF reviews.
- Process and track final essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs, GCP and ICH guidelines.
- Manages the identification of operational issues and resolutions related to the TMF.
- Responsible for gathering data requested by study team to support status reports to clients.
- Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports.
- Participates in client audits and regulatory inspections
- Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends.
- Collaborates with all members of BP and S.
- Ensures overall client satisfaction for all studies.
- Participates in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes.
- Maintains an understanding of applicable regulatory requirements.
- Attend internal or external study team meetings as required.
- Perform other related duties as assigned.
- Perform support activities as required.
- Perform Training 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 8 to 10 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 8 to 10 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.
Learn more about our EEO & Accommodations request here.