Senior Clinical Trial Manager (Medical Device)

Job Title: Senior Clinical Trial ManagerJob Description

We are seeking a highly experienced Senior Clinical Trial Manager to oversee all aspects of clinical trials, from start-up through close-out, ensuring compliance with industry and corporate standards. This role involves managing clinical site interactions, including IRB/EC applications, contract negotiations, and enrollment tracking, while contributing to the preparation of key clinical documents and supporting applications and technical files.

Responsibilities

• Manage all clinical site interactions including IRB/EC applications, contract negotiations, enrollment tracking, and clinical supply requests.

• Own and manage trial start-up, conduct, and close-out activities according to industry and corporate standards.

• Contribute to the preparation of clinical documents such as protocols, informed consent forms, amendments, CRFs, training materials, project plans, monitoring plans, data plans, SAPs, and reports.

• Establish professional rapport and maintain frequent communication with investigational site personnel.

• Track internal metrics, timelines, and budgets.

• Communicate trial status and prepare/present updates to management.

• Oversee monitoring activities to ensure compliance with GCP, ICH, FDA regulations, SOPs, and protocols.

• Collaborate with data management teams to plan and execute analyses.

• Support applications and technical files as needed.

• Collaborate with DSMB, CEC, and other committees.

• Assist with investigators' meetings and manage vendors.

• Travel up to 25% of the time.

• Perform other duties as assigned.

Essential Skills

• 8-10 years of clinical research experience with at least 3-5 years in trial management.

• Must have medical device experience.

• Previous monitoring experience is highly preferred.

• Expertise in IRB/EC submissions and approvals.

• Strong knowledge of clinical documentation, monitoring, and FDA regulations.

• Experience with GCP, ICH, ISO, and FDA requirements.

• Adverse event investigation and reporting experience.

• Vendor and contractor management experience.

• Strong written and verbal communication skills.

• Experience with EDC systems.

• Clinical budget planning and management experience.

Additional Skills & Qualifications

• BA/BS in Science, Life Sciences, or related field.

• Experience in medical device, pharmaceutical, biotech, or CRO clinical trials.

• Cardiovascular experience preferred.

Work Environment

This position offers a hybrid work environment, allowing flexibility between remote and office work. Travel may be required up to 25% of the time, depending on project needs.

Job Type & Location

This is a Contract to Hire position based out of Andover, MA.

Pay and Benefits

The pay range for this position is $70.00 - $80.00/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 Andover,MA.

Application Deadline

This position is anticipated to close on Mar 17, 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 [email protected] (%[email protected]) for other accommodation options.