Senior TMF Specialist - Remote Contract (6 months)

Jobvite, Inc.; Brisbane (CA); Remote; USD 85,000 - 105,000; Full time

Job summary

Arcus Biosciences seeks a Senior Clinical Document Specialist to manage TMF content across one or more clinical programs. You will ensure documents are current, complete, and inspection-ready in line with GCP/ICH guidelines.

Role involves collaboration with SMTs, occasional travel, and potential training of staff. This is a 6‑month full-time contract, remote US, with CRO and partner coordination.

Qualifications

• Bachelor's or Associates degree with 4+ years of clinical trial experience, or high school diploma with 6+ years in regulatory docs.
• Experience with sponsor or CRO trial processes including start-up, conduct, and close-out document collection.
• Familiarity with ICH/GCP guidelines and international trials.
• Experience with Veeva Vault eTMF system including uploading, reviewing, QC, and document approvals.
• Working knowledge of DIA reference model and MS Office tools.

Responsibilities

• Collaborate with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF.
• Serve as TMF SME/point of contact for study teams and TMF stakeholders.
• Review and classify documents collected from internal and external sources.
• Reconcile essential documents to avoid duplication.
• Support TMF quality review processes for study teams.
• Perform QC and maintenance of eTMF for assigned studies.
• Data entry and reconciliation in clinical systems and tracking tools.
• Contribute to revisions of TMF Work Instructions and SOPs.

Skills

TMF management

Documentation

Clinical trial experience

MS Office

Education

Bachelor's degree

Associates degree

Tools

Veeva Vault

MS Office

DIA reference model

Job description

Arcus Biosciences seeks a Senior Clinical Document Specialist to manage TMF content across one or more clinical programs. You will ensure documents are current, complete, and inspection-ready in line with GCP/ICH guidelines.

Role involves collaboration with SMTs, occasional travel, and potential training of staff. This is a 6‑month full-time contract, remote US, with CRO and partner coordination.