Connexion Systems + Engineering
https://www.csetalent.com/wp-content/uploads/2021/04/connexion-social-logo.png
http://www.csetalent.com
http://www.csetalent.com
true
Caroline Driscoll
Associate Director, Document Management
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Associate Director, Document Management & Trial Master File (TMF)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Description:
We are seeking an experienced Associate Director, Document Management & Trial Master File (TMF) to provide strategic and operational leadership for GxP document management across clinical programs. This role is responsible for ensuring TMFs are complete, accurate, and inspection-ready, while leading TMF staff, overseeing vendors, and driving continuous process improvement.
The ideal candidate brings deep hands-on expertise with Veeva Vault eTMF, strong regulatory inspection experience, and proven leadership within a pharmaceutical, biotech, or CRO environment.
Key Responsibilities
TMF Leadership & Oversight
Qualifications
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Title: Associate Director, Document Management & Trial Master File (TMF)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 6+ months contract, with potential for extension or conversion
- Pay rate: $100 - $110/hr
- Job Location: Remote (US)
- Schedule: Â M-F, standard business hours
- Job#: bh18550
Description:
We are seeking an experienced Associate Director, Document Management & Trial Master File (TMF) to provide strategic and operational leadership for GxP document management across clinical programs. This role is responsible for ensuring TMFs are complete, accurate, and inspection-ready, while leading TMF staff, overseeing vendors, and driving continuous process improvement.
The ideal candidate brings deep hands-on expertise with Veeva Vault eTMF, strong regulatory inspection experience, and proven leadership within a pharmaceutical, biotech, or CRO environment.
TMF Leadership & Oversight
- Lead day-to-day TMF/eTMF operations across multiple clinical studies.
- Ensure TMFs are created, maintained, and archived in compliance with SOPs, ICH-GCP, FDA, EMA, and global regulatory requirements.
- Maintain TMFs in a constant state of inspection readiness and support internal audits and health authority inspections.
- Serve as the TMF subject matter expert and escalation point.
- Manage, coach, and develop TMF team members (e.g., TMF Managers, Coordinators, Documentation Specialists).
- Support hiring, onboarding, training, and performance management activities.
- Foster a culture of quality, accountability, collaboration, and continuous improvement.
- Contribute to TMF training programs for both TMF staff and cross-functional partners.
- Oversee TMF vendors, including performance monitoring, issue resolution, and governance meetings.
- Partner with vendors to ensure compliant and efficient use of eTMF systems.
- Collaborate cross-functionally with Clinical Operations, Quality, Regulatory, Pharmacovigilance, Data Management, Drug Supply, and other stakeholders to align TMF expectations and deliverables.
- Act as a primary TMF point of contact for internal and external stakeholders.
- Define, analyze, and report TMF quality and performance metrics related to completeness, timeliness, and inspection readiness.
- Review vendor metrics and follow up on trends, risks, and corrective actions.
- Conduct or oversee TMF QC reviews, gap analyses, and remediation efforts.
- Support and initiate CAPAs related to TMF quality issues.
- Identify risks and inefficiencies within TMF processes and workflows.
- Contribute to the development and maintenance of TMF SOPs, work instructions, and templates.
- Support alignment with industry best practices, including the DIA TMF Reference Model.
- Participate in cross-functional process improvement initiatives.
- Bachelor’s degree in life sciences, biomedical sciences, or a related field (required).
- 7–10+ years of experience in TMF/eTMF management within a pharmaceutical, biotechnology, or CRO environment.
- Strong working knowledge of ICH-GCP, FDA, EMA, and global TMF regulatory requirements.
- Solid understanding of the CDISC/DIA TMF Reference Model.
- Deep hands-on experience with Veeva Vault eTMF, including user management, reporting, system support, and inspection readiness.
- Experience with additional eTMF systems (e.g., Trial Interactive) is a plus.
- Direct experience supporting regulatory inspections and audits (FDA, EMA, etc.), including TMF preparation and remediation activities.
- Proven people management and vendor oversight experience.
- Strong analytical, organizational, and problem-solving skills.
- Excellent communication skills with the ability to work effectively across all organizational levels.
- High attention to detail and a strong commitment to quality and compliance.
- Ability to manage competing priorities in a fast-paced, dynamic environment.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Meet Your Recruiter