Job Description
The Clinical Trial Manager is responsible for managing clinical trial studies within specific therapeutic areas. The role involves providing guidance and oversight to project teams for successful study operations, adhering to GCP/ICH Guidelines, regulatory requirements, company SOPs, and study protocols.
ResponsibilitiesOversee third-party vendors and coordinate responses to audits.Evaluate vendor performance and implement corrective action plans.Provide clinical input and develop necessary clinical documents for regulatory submissions.Manage the planning and execution of investigator meetings.Develop study-specific timelines and coordinate with program timelines.Ensure internal functional areas complete deliverables and manage study issues.Communicate study information effectively to various departments.Identify risks and opportunities in clinical studies and develop mitigation plans.Collaborate with Biometry to develop case report forms and data management plans.Coordinate with the Manager of Supplies for timely manufacturing and shipping of supplies.Work closely with the Manager of Contracts on study budgets and vendor selection.Lead meetings with CROs, vendors, and multi-functional teams to ensure quality and timely deliverables.Review site and vendor invoices to ensure alignment with project expenses.Conduct training for internal staff, CRO staff, vendors, investigators, and study coordinators.Essential SkillsExperience in clinical trial management and ICH GCP guidelines.Oncology, Ophthalmology, and/or Biologics experience.Recent project management experience supporting sponsors and CROs.Strong vendor management skills.Additional Skills & QualificationsProficiency in CTMS tracking systems.Ability to develop robust data management plans and ensure data integrity.
Pay and Benefits
The pay range for this position is $57.00 - $71.32/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 hybrid position in Durham,NC.
Application Deadline
This position is anticipated to close on Jun 20, 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.