Director, Clinical Systems and TMF Oversight

Meet Life Sciences; United States; Remote; USD 200,000 - 240,000; Full time

Job summary

Meet Life Sciences is seeking a Director, Clinical Systems and TMF Oversight for a remote role in the biotech sector. This leadership position requires overseeing clinical systems to ensure TMF compliance, optimizing processes, and managing vendor relationships within oncology trials. Ideal candidates will have significant experience in clinical operations within a small to mid-sized biotech setting and a strong understanding of oncology clinical trials.

Benefits

Annual Bonus

RSUs

Stock options

Qualifications

• 8+ years of clinical operations experience with a focus on clinical systems.
• Proven leadership within a small to mid-sized biotech company.
• Strong expertise in oncology and eTMF systems.

Responsibilities

• Oversee all aspects of clinical systems including eTMF and CTMS.
• Ensure TMF completeness and inspection readiness.
• Collaborate with cross-functional teams to support trial execution.

Skills

Leadership

Clinical Operations

GCP Knowledge

Oncology Clinical Trial Experience

Process Optimization

Tools

eTMF systems (e.g., Veeva Vault)

CTMS platforms

Job description

Director, Clinical Systems and TMF Oversight

Director, Clinical Systems and TMF Oversight

This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$200,000.00/yr - $240,000.00/yr

Additional compensation types

Annual Bonus, RSUs, and Stock options

Direct message the job poster from Meet Life Sciences

Director, Clinical Systems and TMF Oversight (Remote | Biotech | Oncology)

We’re looking for a Director, Clinical Systems and TMF Oversight to join our growing team at an innovative, mission-driven biotech company. This is a remote opportunity ideal for professionals with small to mid-sized biotech experience who are ready to take on a critical leadership role.

About the Role:

In this high-impact position, you will be responsible for overseeing all aspects of clinical systems, including eTMF, CTMS, and other supporting platforms, while ensuring full TMF inspection readiness and compliance across our oncology portfolio. You will play a key role in shaping strategy, optimizing processes, managing vendors, and supporting cross-functional teams to ensure efficient and compliant trial execution.

Key Responsibilities:

• Lead the development, implementation, and oversight of clinical systems (eTMF, CTMS, etc.)
• Ensure TMF completeness, quality, and inspection readiness across all studies
• Collaborate closely with Clinical Operations, QA, Regulatory, and IT functions
• Manage vendor relationships and ensure systems are aligned with GxP and ICH-GCP guidelines
• Drive continuous improvement in TMF processes, tools, and governance
• Provide training, guidance, and mentorship to internal teams and external partners
• Serve as the subject matter expert for clinical systems and TMF oversight during audits and inspections

Qualifications:

• 8+ years of clinical operations experience, with a focus on clinical systems and TMF oversight
• Proven success in a leadership role within a small to mid-sized biotech company
• Strong oncology clinical trial experience is required
• Expertise in eTMF systems (e.g., Veeva Vault) and CTMS platforms
• Deep understanding of GCP, regulatory expectations, and TMF management best practices
• Ability to thrive in a fast-paced, collaborative, and evolving environment

Apply for full company details and job description!

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management, Research, and Other

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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