TMF Document Specialist

Role Summary

Participate in the execution of Phase 1–3 clinical trials by handling, reviewing, and quality-checking clinical trial documents in the Trial Master File (TMF). Ensure adherence to ALCOA++, Good Documentation Practices (GDocP), regulatory requirements, and Standard Operating Procedures (SOPs). Work across multiple Crinetics studies.

Responsibilities

• Performs TMF activities efficiently in compliance with ICH GCP requirements, SOPs, Work Instructions (WIs) local laws and regulations, TMF Management Plan and TMF Content Map
• Supports the maintenance of the TMF, perform TMF document process activities such as reviewing, approving, rejecting, and editing metadata as applicable
• Perform thorough (ALCOA ++) and Good Documentation Practices (GDocP) quality review of documents submitted for filing into the TMF and liaise with Document Owners to resolve any issues or queries identified
• Perform Certified copy process on clinical trial documents, as needed
• Perform redaction on sensitive clinical trial documents, as needed
• Completes routine administrative tasks in a timely manner
• Ensures internal and study-related training are completed per study timelines
• Ensures all study deliverables are completed per Crinetics and study timelines
• Other duties as assigned

Qualifications

• Required: Veeva Vault eTMF experience
• Required: Minimum of 2 years’ experience working in a clinical research (clinical operations) environment with direct “hands-on” TMF experience
• Required: Knowledge of ICH/GCP guidelines, TMF Reference Model
• Required: Solid planning, organizational and time management skills, including the ability to support and prioritize multiple tasks / studies
• Required: Knowledge of clinical trial documents that are maintained in the eTMF
• Required: Knowledge of ALCOA ++ and Good Documentation Practices (GDocP)
• Required: Attention to detail

Additional Requirements

• Physical demands: Sit at a desk for long periods; occasional walking; lifting up to 25 lbs; potential laboratory environment experience and adherence to EHS requirements
• Travel: Up to 5% of time