Crinetics Pharmaceuticals · 1 day ago
TMF Document Specialist
United States
Full-time
Onsite
Entry, Mid Level
$69K/yr - $86K/yr
2+ years expCrinetics Pharmaceuticals is seeking a TMF Document Specialist to participate in the execution of Phase 1-3 clinical trials. The role involves handling, reviewing, and quality checking clinical trial documents in the Trial Master File (TMF) while ensuring compliance with quality standards and regulatory requirements.
BiotechnologyHealthcarePharmaceuticalHealth CareTherapeutics
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
Qualification
Required
Veeva Vault eTMF experience
Minimum of 2 years' experience working in a clinical research (clinical operations) environment with direct “hands-on” TMF experience
Knowledge of ICH/GCP guidelines, TMF Reference Model
Solid planning, organizational and time management skills, including the ability to support and prioritize multiple tasks / studies
Knowledge of clinical trial documents that are maintained in the eTMF
Knowledge of (ALCOA ++) and Good Documentation Practices (GDocP)
Attention to detail
Benefits
Discretionary annual target bonus
Stock options
ESPP
401k match
Top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
Winter company shutdown
Company
Crinetics Pharmaceuticals
Crinetics is a clinical-stage pharmaceutical company that develops therapies for people with rare endocrine diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2BKey Investors
Frazier Healthcare PartnersNational Institutes of HealthPerceptive Advisors
2026-01-06Post Ipo Equity· $349.22M
2024-10-08Post Ipo Equity· $500M
2024-02-28Post Ipo Equity· $350M
Leadership Team
R. Scott Struthers
Founder, CEO
A
Alan S. Krasner
Chief Endocrinologist
Recent News
BioWorld Financial Watch
2026-01-15
Company data provided by crunchbase