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Actalent Senior Study Manager in Basking Ridge, New Jersey

Our Client is seeking a Senior Study Manager to oversee the delivery and execution of clinical studies at a global level. This dynamic and challenging role requires adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and international regulations. The incumbent will engage in routine interaction with key stakeholders, ensuring effective communication and resolution of issues.

Responsibilities

  • Lead the development and execution of clinical study plans, including critical path activities and interdependencies for assigned clinical studies.

  • Create and manage the cross-functional Clinical Study Oversight Plan, ensuring adherence and documentation.

  • Provide operational input into study protocol profiles, final protocols, and amendments.

  • Lead the CRO and vendor selection process in collaboration with the study team and manage the creation of the CRO scope of work.

  • Oversee trial feasibility, site identification, and qualification processes.

  • Monitor clinical trial performance and quality metrics, ensuring timely actions and escalation of issues.

  • Ensure adherence to internal procedures for study planning, conduct, close-out, and reporting.

  • Proactively assess potential risks and propose mitigation plans.

  • Monitor study budget and approve vendor invoices, ensuring reconciliation with Finance.

  • Oversee and manage CRO and 3rd party vendor performance to ensure compliance with quality measures.

  • Coordinate meetings and liaise with internal and external stakeholders to support study activities.

  • Support department in codifying knowledge and best practices and prepare training in areas of expertise.

    Skills & Qualifications

  • 7+ years of experience in clinical operations with a pharmaceutical or biotech company.

  • Experience in clinical trial study start-up and patient enrollment.

  • Robust experience in vendor/CRO oversight and management.

  • Experience in oncology studies, particularly with solid tumors.

  • Global study experience, including knowledge of Asia-Pac and Latin America regions.

  • Bachelor's degree in Science or an advanced degree.

Work Environment

  • This is a 100% remote role, with candidates required to be in the Eastern Time Zone or local to the NJ/PA/NY area.

  • Candidates should be open to and flexible with face-to-face meetings.

Job Type & Location

This is a Contract to Hire position based out of Basking Ridge, NJ.

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 Mar 13, 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 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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