Sr. Clinical Trial Manager
Actalent
The Senior Clinical Trial Manager will oversee the execution of clinical studies across multiple geographic regions, ensuring compliance with Good Clinical Practices, Standard Operating Procedures, FDA regulations, and ICH guidelines. This role involves interaction with both internal and external stakeholders and requires strong communication, decision-making, and clinical project management skills. The position reports to an Associate Director responsible for Operational Study Strategy and may involve both strategic and execution responsibilities.
Responsibilities
+ Lead the development of clinical study plans, including critical path activities and interdependencies.
+ Create and manage the Clinical Study Oversight Plan, ensuring adherence by study teams and vendors.
+ Provide operational input into study protocol profiles and amendments.
+ Coordinate document reviews and medical writing tasks, such as ICF, CRF guidelines, and safety communications.
+ Manage CRO and vendor selection processes in collaboration with study teams.
+ Oversee trial feasibility, site identification, and qualification activities.
+ Monitor clinical trial performance and quality metrics, addressing issues and risks as needed.
+ Ensure adherence to internal procedures for study planning, conduct, and reporting.
+ Monitor study budget and ensure alignment with financial expectations.
+ Oversee CRO and third-party vendor management, ensuring compliance with quality measures and timelines.
+ Coordinate operational activities, including interim analysis and study close-out tasks.
+ Support departmental knowledge sharing and training initiatives.
Must Have Experience
+ Expertise in oncology and clinical operations.
+ Proficiency in CRO management and patient enrollment.
+ 7+ years of experience in the pharmaceutical or biotech industry.
+ Experience with clinical study start-up, site management, and global clinical study management.
+ Experience in vendor management and recruitment strategies.
Additional Qualifications
+ Bachelor's degree in Science or related field.
Pay and Benefits
The pay range for this position is $85.00 - $95.00/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 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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