Job Description

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 business needs.

of Responsibilities:

• 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 document classification, ARC review, (when applicable)
• 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 company UCV and TMF Review, if applicable (TMF Reviewers) and responsible for performing QC into Sponsor system (TMF Classifier) if applicable.
• Maintains the TMF in a state of audit readiness for quality and compliance by:
• Visual quality checks of e-documents prior to release to confirm image clarity and readability.
• Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate;
• Comply with metrics established for performance.
• Process and track final essential artifacts required throughout all phases of the study in accordance with company SOPs, sponsor SOPs, GCP and ICH guidelines.
• Manages the identification of operational issues and resolutions related to the TMF.
• Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports.
• Participates in Internal Audits and Client Audit as per study requirements.
• 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 Training and Mentoring as required.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelor’s Degree with a' Life Sciences/Business focus.

Experience (Minimum Required):

• Minimum 4 to 8 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.
• Excellent interpersonal skills.

Preferred Qualifications Include:

• Masters’s Degree with a Life Sciences/Business focus.
• Equivalent experience within clinical research environment of a minimum of 6 to 10 years, may be substituted for education requirements.
• Experience working in clinical electronic systems.

Physical Demands/Work Environment:

• Minimal (less than 10%) as required for Sponsor Kick-Off Meetings, Face to Face Client Meetings, when requested.

Learn more about our EEO & Accommodations request here