CAREER PORTAL

Clinical Trial Master File Specialist

Position Title: Contract TMF Specialist – Clinical Operations
Location: Remote
Type: 6 month contract
Pay: $40-50/hr

About the Company:
Our client is a clinical-stage biotech company advancing precision medicine therapies in oncology. Our mission is to bring targeted treatments to patients by leveraging translational science, molecular insights, and small molecule drug discovery. Our diverse pipeline is built on novel approaches to address genetically defined cancer populations and drive more effective responses to treatment.
You’ll join a collaborative and driven team that values scientific rigor, proactive thinking, and a shared commitment to improving patient outcomes. Our environment encourages asking bold questions, working cross-functionally, and moving fast — all while staying rooted in purpose. Position Summary:
We are seeking an experienced and detail-oriented Contract TMF Specialist to manage and maintain both paper and electronic Trial Master Files (TMFs) across our clinical studies. This individual will play a critical role in ensuring GCP compliance, inspection readiness, and documentation integrity throughout the lifecycle of our trials.
The TMF Specialist will work closely with internal clinical teams, CRO partners, and eTMF vendors to execute TMF plans, ensure completeness of essential documents, and support clinical operations in alignment with regulatory standards. This is a high-impact role for someone who thrives in a fast-paced, oncology-focused environment.

Key Responsibilities:

• Support internal TMF operations to ensure trial documentation is maintained accurately and in a state of audit readiness.
• Collaborate with clinical study teams and CRO partners to manage TMF plans, indexes, and document flow across studies.
• Maintain oversight of TMF health by tracking completeness, timeliness, and quality of documents in accordance with study-specific TMF plans.
• Perform quality control (QC) reviews of TMF documents throughout study phases, from startup to closeout, ensuring regulatory compliance and data integrity.
• Monitor TMF metrics and key performance indicators (KPIs); identify areas for process improvement and recommend corrective actions.
• Serve as eTMF system administrator (e.g., Veeva Vault), managing configurations and supporting user access, training, and system optimizations.
• Partner with cross-functional teams (Clinical Operations, Regulatory, Quality, etc.) to align on TMF expectations and inspection readiness strategies.
• Provide TMF-related support during audits and regulatory inspections, including locating documents and preparing response packages.
• Contribute to the development of SOPs, workflows, and training materials related to TMF management.

Qualifications:

• Bachelor’s degree in life sciences or related discipline required.
• Minimum 4 years of experience in TMF management within the biotech/pharma industry.
• Strong working knowledge of eTMF systems; experience with Veeva Vault is required.
• Familiarity with the TMF Reference Model and cross-functional clinical processes.
• Demonstrated understanding of ICH GCP and global regulatory requirements related to TMF documentation.
• Prior experience supporting inspection readiness activities is highly desirable.
• Excellent organizational, time management, and communication skills.
• Comfortable in a fast-paced, collaborative environment; proactive and solutions-focused mindset

 

Estimated Min Rate: $40.00
Estimated Max Rate: $50.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.