Job Title: Clinical Documentation Specialist

Job Description

Manage Phase I to IV study activities. Ensure the Trial Master File is always inspection-ready and complies with ICH GCP guidelines. This role involves regularly updating and assisting study teams to address issues related to key Trial Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.

Responsibilities

• Manage Phase I to IV study activities.
• Ensure the Trial Master File is always inspection-ready and complies with ICH GCP guidelines.
• Regularly update and assist study teams to address issues related to key Trial Master File health indicators.
• Ensure the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.

Essential Skills

• Clinical trial management
• TMF (Trial Master File)
• Knowledge of FDA, ICH, and GCP guidelines
• Clinical research and pharmaceutical documentation
• Document control and regulatory documents management
• Clinical operations and clinical documentation

Additional Skills & Qualifications

• BS Degree
• 3-5 years of Clinical Research/Clinical Documentation experience with TMF for Phase I-IV studies
• Experience with Expected Document Lists (EDLs)
• Experience with TMF Management Plans

Work Environment

100% remote

Pay and Benefits

The pay range for this position is $30.00 - $35.00/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 22, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $35