Job Information
Actalent Senior Clinical Trial Manager in Andover, Massachusetts
Job Title: Clinical Trial Manager
Job Description
The Clinical Trial Manager leads complex global clinical trials from start-up through close-out, with a strong focus on medical device studies in the cardiovascular space. This role oversees all clinical site interactions, ensures compliance with regulatory and quality standards, and drives successful execution of trials that support innovative organ care technologies. The position requires deep expertise in clinical research operations, strong collaboration with cross-functional teams and external partners, and a commitment to improving patient outcomes through high-quality clinical evidence.
Responsibilities
Lead and manage all clinical site interactions, including IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, and issue resolution.
Own and manage all trial start-up, conduct, and close-out activities in accordance with industry best practices and corporate standards.
Contribute to the preparation and review of key clinical documents, including protocols, informed consent forms, amendments, case report forms (CRFs), training materials, project plans, monitoring plans, data management plans, statistical analysis plans (SAPs), and study reports.
Establish and maintain strong professional relationships and frequent communication with investigational site personnel to support enrollment, compliance, and data quality.
Track and report internal metrics, timelines, and budgets to ensure trials remain on schedule and within agreed parameters.
Communicate trial status clearly and regularly, preparing and presenting updates and summaries to management and relevant stakeholders.
Oversee monitoring activities to ensure adherence to GCP, ICH, FDA regulations, ISO standards, standard operating procedures (SOPs), and study protocols.
Collaborate closely with data management teams to plan, coordinate, and execute data collection, cleaning, and analysis activities.
Support regulatory and technical documentation needs, including applications and technical files related to clinical trials.
Work collaboratively with independent committees such as Data Safety Monitoring Boards (DSMB), Clinical Events Committees (CEC), and other oversight bodies.
Assist in planning and conducting investigators’ meetings, including agenda development, content review, and meeting logistics.
Manage and oversee vendors and contractors, including CROs and other external partners, to ensure high-quality deliverables and compliance with timelines and budgets.
Contribute to adverse event investigation and reporting processes, ensuring timely and accurate documentation in line with regulatory requirements.
Participate in clinical budget planning and ongoing budget management for assigned studies.
Travel up to 25% of the time to clinical sites, meetings, and internal locations as needed.
Perform other clinical trial management duties as assigned to support the success of the clinical program.
Essential Skills
8–10 years of clinical research experience with at least 3–5 years specifically in clinical trial management.
Medical device clinical trial experience, including direct trial management responsibilities.
Experience in clinical trials within medical device (preferred), pharmaceutical, biotech, or CRO environments.
Previous monitoring experience, with strong understanding of on-site and remote monitoring practices.
Expertise in IRB/EC submissions, approvals, and ongoing communications.
Proven track record leading complex global clinical trials from initiation through close-out.
Strong knowledge of clinical documentation requirements, including protocols, informed consent forms, CRFs, and study reports.
In-depth understanding of FDA regulations and regulatory expectations for clinical trials.
Hands-on experience with GCP, ICH, ISO, and FDA requirements and their practical application in clinical operations.
Experience in adverse event investigation, assessment, and reporting.
Vendor and contractor management experience, including oversight of CROs and other clinical service providers.
Proficiency with electronic data capture (EDC) systems and related clinical technologies.
Experience with clinical budget planning, tracking, and management.
Strong written and verbal communication skills for effective interaction with sites, vendors, internal teams, and leadership.
High level of organization, attention to detail, and results-driven mindset.
BA/BS degree in Science, Life Sciences, or a related field.
Additional Skills & Qualifications
Cardiovascular clinical trial experience, particularly in high-acuity or advanced therapies, is preferred.
Experience working with CTMS and eTMF systems to manage study information and documentation.
Experience in medical device trials that may include, but is not limited to, transplant or organ care technologies.
Demonstrated ability to collaborate with cross-functional teams, including data management, biostatistics, regulatory, and quality.
Experience supporting or interacting with DSMB, CEC, and other independent oversight committees.
Comfort presenting trial status, risks, and mitigation plans to leadership.
Ability to manage multiple priorities and studies in a fast-paced, evolving environment.
Strong problem-solving skills with the ability to address site-level and study-level issues proactively.
Work Environment
This position operates in a hybrid work environment. During the first 2–3 months, the role is fully onsite to support onboarding, training, and integration with the clinical and cross-functional teams. After this initial period, the schedule transitions to four days onsite and one day remote each week. The work involves close collaboration with internal clinical operations, data management, regulatory, and quality teams, as well as frequent interaction with external sites, vendors, and oversight committees. The environment is mission-driven and focused on advancing organ care technologies that improve transplant outcomes and expand access to life-saving therapies. The role may require up to 25% travel to clinical sites, internal meetings, and external events.
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 Apr 30, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.