US - TMF Archivist

Advanced Clinical; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k benefits

Job summary

Advanced Group is seeking a TMF Archivist to manage Trial Master File (TMF) and records, oversee study closures, archiving, and retention in compliance with regulatory requirements. The role covers paper and electronic records, TMF transfers, ISF retention, and inspection readiness.

The candidate will coordinate with internal teams and vendors, ensure chain of custody, and support audits while working on-site in Delaware with possible travel up to 20%.

Qualifications

• 10 years of experience in clinical trials research within the pharmaceutical industry
• Bachelor’s degree in a scientific, healthcare, life sciences, or related discipline, or equivalent relevant experience
• Experience with Veeva Vault TMF and familiarity with other TMF systems
• Experience with paper and electronic clinical document management
• Experience managing or supporting TMF transfers and migrations
• Strong knowledge of ICH-GCP and global regulatory requirements for TMF management, archival and retention
• Strong organizational skills and ability to manage multiple priorities
• Detail-oriented and proactive problem-solving skills
• Good written and verbal communication skills
• Must be able to be on-site in the Delaware office monthly, with possible international travel up to 20%

Responsibilities

• Coordinate TMF study closure and archival activities and monitor TMF health
• Coordinate with internal stakeholders and vendors for secure transfer, storage, retrieval, and disposition of records
• Coordinate reconciliation, inventory, transfer, shipment, storage, retrieval, and archival of paper records
• Coordinate TMF transfers and migrations, including planning, mapping, reconciliation, and quality verification
• Coordinate reconciliation of TMF records during early termination of sites/countries/trials
• Respond to closure mailbox queries in a timely manner
• Support ISF questions on retention requirements and storage
• Serve as SME for TMF archival/retention during audits and inspections
• Support the TMF Director and TMF Specialists as needed

Skills

Organizational skills

Written & verbal communication

Attention to detail

Teamwork

Microsoft Office

Record management

Education

Bachelor's degree in life sciences or related field

Tools

Veeva Vault TMF

Job description

JOB DESCRIPTION

Job Summary

The TMF Archivist is responsible for managing and overseeing Trial Master File (TMF) and record management activities, study closure, archival and retention. The role supports the compliant management of paper and electronic clinical trial records, TMF transfers and migrations, Investigator Site File (ISF) retention support, and inspection readiness in accordance with applicable regulatory requirements and company procedures.

Summary of the Essential Functions of the Job

• Coordinate and oversee TMF study closure and archival activities, including monitoring TMF health, tracking closure activities, ensuring required EDL/placeholder reconciliation and milestone completion, coordinating TMF lock timelines, and providing final archival sign-off.
• Coordinate with internal stakeholders and external archival/records management vendors to support secure transfer, storage, retrieval, and disposition of clinical trial records.
• Coordinate the reconciliation, inventory, transfer, shipment, storage, retrieval, and archival of paper clinical trial records, ensuring appropriate chain of custody and traceability are maintained.
• Coordinate and support the TMF/SSU Compliance team with TMF transfers and migrations, including migration planning, document and metadata mapping, reconciliation, quality verification, issue resolution, and confirmation of successful transfer.
• Coordinate with study teams to reconcile TMF records when sites, countries, or trials are terminated early, ensuring all applicable records are identified, collected, and filed based on the circumstances of the early termination.
• Ensure all queries to the closure mailbox are responded to in a timely manner.
• Support the study teams with Investigator Site File (ISF) questions on retention requirements and storage.
• Serve as a subject matter resource for TMF archival and retention processes during audits and regulatory inspections, including supporting document retrieval of archived records.
• Support the TMF Director and TMF Specialists as needed.

Minimum Requirements

• 10 years of experience in clinical trials research within the pharmaceutical industry.
• Bachelor’s degree in a scientific, healthcare, life sciences, or related discipline, or equivalent relevant experience.
• Experience working within the Veeva Vault TMF and familiarity with other TMF systems.
• Experience with both paper and electronic clinical document management.
• Experience managing or supporting TMF transfers and migrations.
• Strong knowledge of ICH-GCP and applicable global regulatory requirements and guidance related to clinical trial records, TMF management, archival, and retention.
• Strong organizational skills and ability to manage multiple priorities.
• Detail-oriented and proactive problem-solving skills.
• Good written and verbal communication skills.
• Excellent Microsoft Office and record management system skills.
• Ability to work both independently and as part of a team in a fast-paced environment.
• Must be able to be on-site in the Delaware office monthly, with possible international travel up to 20%.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].