Senior Clinical Trial Manager

Job Title: Senior Clinical Trial Manager

Job Description

Join our dynamic team as a Senior Clinical Trial Manager where you will play a pivotal role in leading, overseeing, planning, and executing assigned clinical studies. Collaborate closely with the Clinical Program Manager and other departments to ensure the successful delivery of key project milestones.

Responsibilities

• Collaborate with the Clinical Program Manager to lead and oversee clinical studies, ensuring timely execution and delivery of key deliverables.

• Work closely with Clinical Outsourcing to select CROs and vendors, manage RFI, RFP, bid defenses, and handle contract and budget negotiations.

• Make primary decisions on CRO and vendor selection alongside the Clinical Program Manager and Director of Clinical Outsourcing.

• Oversee relationships with CROs, vendors, field monitors, and other partners; establish and maintain strong relationships with investigators, study coordinators, site personnel, and other external stakeholders.

• Develop and manage study budgets and financial reporting, including monthly and quarterly financial reconciliation and forecasting.

• Monitor study status and timelines, providing data for performance metrics reporting.

• Work with the Patient Recruitment department to strategize recruitment efforts, meet enrollment projections, and achieve established targets.

• Oversee the development of clinical study documents including ICF, monitoring plans, and recruitment plans.

• Lead and participate in internal cross-functional clinical team meetings, serving as the main point of contact for study-level status updates.

• Provide study-level updates at management meetings and other forums.

• Coordinate study start-up activities with relevant departments, including feasibility studies and regulatory document preparation.

• Participate in database creation, user acceptance testing, and data cleaning activities.

• Contribute to SOP development, process mapping, and training of junior CTMs and CTAs.

• Directly manage and supervise CTMs and/or CTAs, conducting performance reviews and supporting their professional development.

Essential Skills

• Proven experience in clinical trial management, project management, and vendor management.

• 7-10+ years of clinical research experience in pharmaceutical/biotech or CRO settings.

• Experience in managing CROs, vendors, budgets, and study timelines.

• Hands-on involvement in study start-up, patient recruitment, and clinical documentation.

• Strong knowledge of GCP/ICH guidelines for conducting clinical trials.

• Excellent leadership, interpersonal, organizational, and multi-tasking skills.

• Attention to detail and problem-solving capabilities.

• Ability to work effectively in a team setting.

Additional Skills & Qualifications

• Science or healthcare degree required, with a Master's degree preferred.

• Experience in neurology, such as narcolepsy, is a plus.

• Phase I clinical trial experience is advantageous.

Work Environment

This is a hybrid role requiring three days a week on-site in Waltham, MA.

Job Type & Location

This is a Contract position based out of Waltham, MA.

Pay and Benefits

The pay range for this position is $85.00 - $85.00/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 hybrid position in Waltham,MA.

Application Deadline

This position is anticipated to close on Dec 5, 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 [email protected] (%[email protected]) for other accommodation options.