Senior Clinical Study Manager

Actalent; New York (NY); Remote; USD 60,000 - 80,000; Full time

Job summary

Actalent is seeking a Senior Clinical Study Manager to oversee the execution of clinical studies across various regions. This fully remote role requires a strong background in clinical trial management, particularly in oncology, and offers a competitive hourly pay rate. The successful candidate will lead project planning, vendor management, and ensure compliance with regulatory standards.

Benefits

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick Leave)

Qualifications

• 7+ years of experience as a GLOBAL Clinical Trial Manager.
• 5+ years of global experience within oncology (SOLID TUMORS).
• Experience leading Phase II or III global studies.

Responsibilities

• Lead the development of clinical study plans and manage CROs.
• Monitor clinical trial performance and quality metrics.
• Coordinate study-related meetings and training sessions.

Skills

Project Management

Stakeholder Communication

Clinical Trial Management

Regulatory Compliance

Budget Management

Education

Bachelor of Science degree or higher

Job description

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Job Title: Senior Clinical Study Manager

The Senior Clinical Study Manager is responsible for ensuring the successful execution and delivery of clinical studies across various geographic regions, adhering to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines. This role requires extensive interaction with internal and external stakeholders to communicate project status, address issues, and provide expert-level guidance. The position reports to an Associate Director and involves both strategic planning and operational execution of clinical studies.

Responsibilities

• Lead the development of clinical study plans, identifying critical path activities and interdependencies.
• Create and manage the Clinical Study Oversight Plan, ensuring adherence and documentation of activities by CROs and vendors.
• Provide operational input into study protocols and amendments, and lead document review and coordination.
• Oversee CRO and vendor selection, scope of work creation, and ensure compliance with quality measures and timelines.
• Monitor clinical trial performance and quality metrics, escalating issues and proposing solutions as necessary.
• Ensure study adherence to internal procedures for planning, conduct, close out, and reporting.
• Monitor and reconcile study budgets, reviewing vendor invoices and ensuring alignment with Finance.
• Coordinate study-related meetings and training sessions, including vendor kick-off and investigator meetings.
• Support department in codifying knowledge and best practices, and prepare training materials.
  
  

Additional Skills & Qualifications

• 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or biotech company.
• 5+ years of global experience within oncology (SOLID TUMORS!)
• Bachelor of Science degree or higher.
• Experience leading Phase II or III global studies within oncology
• Experience working for a Japanese company is a plus.
  
  

Work Environment

The team consists of a team lead and three study managers, with responsibilities in vendor management and regional assignments. The team operates in either the EU or US-Latin America regions, managing timelines, budgets, site activation, and enrollment. The role requires experience in study management, global experience, and overseeing CROs for study management activities.

Pay and Benefits

The pay range for this position is $90.00 - $98.00/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 2, 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 [e-mail] for other accommodation options.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Business Consulting and Services

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