Clinical Study Manager

About the role

This role is for an experienced Global Clinical Study Manager who leads complex, multinational oncology trials.

Responsibilities

• Lead the end-to-end operational delivery of assigned global clinical studies, with primary accountability for time, cost, and quality outcomes.
• Develop comprehensive clinical study plans, including critical path activities, interdependencies, and timelines, using tools such as Microsoft Project.
• Lead the creation and implementation of cross-functional Clinical Study Oversight Plans, ensuring study team, CRO, and vendor adherence and proper documentation.
• Provide operational input into study protocol profiles, final protocols, and amendments to ensure feasibility and operational excellence.
• Coordinate and lead document review for protocols and amendments, and contribute to medical writing activities such as informed consent forms, case report form guidelines, investigator brochures, safety communications, DSURs, and IND-related documents.
• Drive and oversee CRO and vendor selection in collaboration with the study team and outsourcing/procurement functions, ensuring alignment with study needs and timelines.
• Manage trial feasibility and site identification activities in collaboration with the CRO and study team, and oversee the site qualification process.
• Maintain strict adherence to internal procedures for study planning, conduct, close-out, and reporting, maintaining an inspection-ready mindset throughout the study lifecycle.
• Track and monitor study budgets against trial progress, flag deviations to program and study leadership, and review and approve vendor invoices, including investigator grants and pass-through costs.
• Ensure CROs deliver high-quality, timely study documents and plans, including communication plans, site monitoring plans, and other operational documentation.
• Oversee CRO study start-up activities, coordinating with functional groups to ensure collection of essential site documents and timely site initiation in line with the study plan.
• Coordinate with CROs to plan and execute operational meetings, including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training sessions.
• Manage and oversee third-party vendors such as translation services, trial insurance providers, and central laboratories, ensuring alignment with study requirements and timelines.
• Review CRO-generated reports, including monitoring visit reports, protocol deviation reports, and site metric analyses, identify areas of concern, and resolve issues or escalate them to study leadership as appropriate.
• Collaborate with Quality Assurance teams on site audit and inspection activities, ensuring operational readiness and effective follow-up on findings.
• Conduct and/or oversee CRO oversight monitoring visits (CROOM visits) as outlined in the Clinical Study Oversight Plan, documenting findings and ensuring corrective actions.
• Support the department in codifying existing knowledge, best practices, and lessons learned, and prepare and deliver training in areas of expertise.
• Recommend process improvements and innovations at the study and departmental level, and educate teams on SOPs, GCPs, and optimal use of operational tools.
• Maintain strong, routine communication with internal and external stakeholders, providing clear project status updates, escalating issues, and responding to operational inquiries.
• Act as a strong partner to other Study Managers and study leadership, contributing to a collaborative, high-performance team culture.

  Qualifications

  • Bachelor's degree is a must.
  • 5–6+ years of clinical and global study management experience in pharmaceutical or biotechnology settings.
  • At least 5+ years of oncology global clinical trial experience.
  • Proven ability to work collaboratively and in a team-oriented manner, while managing changing priorities and complex global studies.
  • Proactive problem-solving skills, with the ability to identify issues early and drive practical solutions.
  • Comfort working with and overseeing complex multinational trials, including coordination across regions and vendors.
  • High level of professionalism, positive energy, and strong cultural and team fit, with the ability to build trust and partnerships across study leadership and peers.

    Job Type & Location

    This is a Contract to Hire position based out of New York, NY.

    Pay And Benefits

    The pay range for this position is $85.00 - $90.00/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.

    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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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.