Clinical Study Manager

Global Clinical Study Manager

This role is for an experienced Global Clinical Study Manager who leads complex, multinational oncology trials. Must be located in EST Time zone.

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.
• Lead the development of CRO scopes of work in partnership with outsourcing and procurement, clearly defining deliverables, timelines, and performance expectations.
• Manage trial feasibility and site identification activities in collaboration with the CRO and study team, and oversee the site qualification process.
• Monitor clinical trial performance and quality metrics at study, country, and site levels, sharing updates with study teams and program leadership, and ensuring timely corrective and preventive actions.
• Proactively identify, triage, and resolve or escalate study issues and risks to the Operations Program Lead and study team leader, and propose mitigation plans.
• Ensure 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.
• Work with Finance to reconcile study budgets on an ongoing basis, ensuring accurate financial tracking and forecasting.
• Provide oversight, performance management, and operational guidance to CROs and third-party vendors to ensure compliance with quality standards, scope of work, timelines, and budget.
• 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.
• Track site initiation and enrollment at country and site levels, and develop and implement enrollment mitigation strategies in collaboration with the CRO when challenges arise.
• 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.
• Coordinate operational activities with the study team leader and CRO to support interim analyses, database lock, and review of tables, listings, and figures before and after database lock.
• Oversee CRO study close-out activities, including TMF reconciliation, and liaise with internal functions to ensure completion of drug destruction and other close-out processes.
• 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 Skills

• Bachelors 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.

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

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)

This is a fully remote position.

This position is anticipated to close on Aug 12, 2026.

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 View email address on click.appcast.io for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.