Trial Master File Specialist

Job Title:

Trial Master File Specialist Job Description We are seeking a dedicated Trial Master File Specialist to assist in in-house TMF operations and support clinical development. You will collaborate with clinical study teams to manage study TMF plans and indexes in partnership with CRO partners and TMF vendors. This role requires a strong partnership with cross-functional teams to ensure TMF quality, timeliness, and completeness throughout the lifecycle of the studies. Responsibilities Maintain TMF configurations, processes, procedures, and training materials that adhere to regulatory requirements. Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up to study closeout/archival and preparation for inspections. Collaborate with clinical study teams to monitor TMF inventory lists, metrics, periodic TMF reviews according to study-specific TMF plans, oversee KPIs, and identify areas for improvement. Serve as an eTMF business administrator, including monitoring the impact of configuration changes to optimize performance. Support TMF elements of regulatory inspections by providing relevant documents and responses as needed. Essential Skills Proficiency with TMF, GCP, and eTMF systems. Experience in managing paper and electronic trial master files. Expertise in Veeva Vault system (e.g., eTMF). Understanding of TMF reference model and cross-functional clinical processes. Excellent planning, organizational, and time management skills. Self-motivated with the ability to evaluate and resolve complex problems. Expertise in quality and GCP requirements to ensure compliance with ICH GCP and other global regulatory guidelines or laws. Excellent written and verbal communication skills. Additional Skills & Qualifications Bachelor's degree in Life Sciences or an advanced degree. A minimum of 4 years of experience maintaining eTMF system(s). Prior inspection readiness experience is highly desired. Work Environment This is a remote position based in the Pacific Standard Time (PST) zone. Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $42.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.

Application Deadline This position is anticipated to close on Apr 3, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.