Job Description
We are seeking a dedicated Quality Assurance professional with a BA/BS degree and a strong background in Clinical Trial Management. This role requires a minimum of 3 years of experience for Clinical Trial Managers (CTM) and 5 years for Senior CTM positions. The ideal candidate must be willing to travel both domestically and internationally, and possess a comprehensive understanding of FDA, EMA, GCP, and ICH regulations and guidelines. This position demands a detail-oriented individual who can provide effective leadership to clinical sites and Contract Research Organizations (CROs).
ResponsibilitiesManage clinical trials independently with a focus on Phase I gene therapy.Provide oversight and direction to CROs to ensure compliance and quality standards.Demonstrate knowledge of FDA/EMA/GCP/ICH regulations and guidelines.Travel domestically and internationally to oversee trial sites.Take initiative in problem-solving and ensure trial protocols are adhered to.Collaborate effectively in a team setting while also working independently.Essential SkillsMinimum 3 years of Clinical Trial Management for CTM and 5 years for Senior CTM.Experience in Phase I clinical trials, particularly in gene therapy.Strong understanding of FDA/EMA/GCP/ICH regulations and guidelines.Ability to manage and interact with CROs.Proven global experience in clinical trials.Additional Skills & QualificationsBA/BS Degree.Strong multi-tasking, time management, and organizational skills.Detail-oriented with excellent problem-solving capabilities.Work Environment
The work environment involves managing clinical trials, which may require travel to various sites internationally and domestically. You will be working with advanced gene therapy technologies in a collaborative team setting. The role demands flexibility and adaptability in a dynamic clinical trial environment, ensuring compliance with industry regulations while overseeing the trials.
Pay and Benefits
The pay range for this position is $50.00 - $63.00/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 Jul 4, 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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.