Job Information
Actalent Clinical Trial Manager in Boston, Massachusetts
Job Title: Clinical Trial Manager
Job Description
The Clinical Trial Manager supports the Clinical Operations team in planning, executing, and managing clinical trials across all phases, with a strong focus on oncology. This role coordinates cross-functional activities, oversees vendors and investigational sites, and ensures that trials meet timelines, quality standards, and regulatory requirements. The position plays a key part in trial oversight, proactive issue resolution, and maintaining high-quality clinical documentation and Trial Master File (TMF) management.
Responsibilities
Plan, execute, and manage clinical trials across all phases in alignment with study protocols, regulatory requirements, and internal standard operating procedures.
Support the Clinical Operations team in day-to-day trial management activities, ensuring operational excellence and adherence to study timelines.
Liaise directly with cross-functional teams, including clinical, regulatory, data management, and other relevant stakeholders, to coordinate trial activities and resolve issues.
Serve as a primary operational contact for investigational sites, contract research organizations (CROs), and ancillary vendors, ensuring effective communication and oversight.
Oversee vendor management activities, including tracking deliverables, monitoring performance, and supporting issue escalation and resolution as needed.
Ensure compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and all applicable clinical research regulations.
Maintain robust trial oversight by tracking and logging study progress, key milestones, and risk indicators, and proactively addressing potential delays or challenges.
Manage and oversee TMF and clinical documentation to ensure completeness, accuracy, and inspection readiness at all times.
Assist with the development, review, and coordination of clinical study plans and related documentation in compliance with regulatory requirements, SOPs, and study timelines.
Utilize clinical trial management systems, cloud-based platforms, and TMF management systems to track activities, metrics, and documentation.
Support audit readiness activities and participate in audits or inspections as needed, ensuring high-quality records management and documentation practices.
Work independently with minimal supervision, escalating only major or critical issues while driving day-to-day operational decisions.
Collaborate with internal stakeholders to adapt plans and priorities in a dynamic, small biotech or startup environment.
Contribute to continuous improvement of clinical operations processes, tools, and best practices based on hands-on trial management experience.
Essential Skills
Minimum of 6 years of experience in clinical operations within the biotech or pharmaceutical industry, including at least 2–3 years of direct clinical trial management experience.
Oncology clinical trial experience, with solid tumor experience strongly preferred.
Experience in a Senior Clinical Trial Associate (Sr. CTA) or Clinical Trial Manager (CTM) role in the biopharmaceutical industry.
Strong understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical research regulations.
Demonstrated experience with clinical trial management software platforms and cloud-based clinical systems.
Hands-on experience with Trial Master File (TMF) management systems and high-quality clinical documentation practices.
Proficiency in project management within a clinical trial setting, including planning, tracking, and oversight of timelines and deliverables.
Proven vendor management experience, including oversight of CROs and ancillary vendors.
Ability to work independently with minimal supervision and to escalate only major and critical issues appropriately.
Excellent communication skills, both written and verbal, to effectively interact with internal teams, sites, and external partners.
Strong organizational skills and attention to detail, with the ability to manage multiple tasks and priorities simultaneously.
Effective problem-solving skills, with a proactive approach to identifying and resolving operational issues.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Experience supporting or participating in audits, with an understanding of audit readiness requirements.
Additional Skills & Qualifications
Bachelor’s degree in a life science or healthcare-related field.
Experience in a small biotech or startup environment, with the ability to adapt to changing priorities and operate in a fast-paced setting.
Experience with oncology trials focused on innovative modalities such as antibody-drug conjugates (ADCs) is advantageous.
Familiarity with managing phase-specific clinical trial activities, with early-phase experience preferred.
Comfort working in a growing organization entering key stages of development, contributing to the build-out of processes and capabilities.
Ability to collaborate effectively across cross-functional teams and contribute to a culture of scientific rigor and operational excellence.
Job Type & Location
This is a Permanent position based out of Boston, MA.
Pay and Benefits
The pay range for this position is $140000.00 - $165000.00/yr.
Health, Dental, Vision, 401k, targeted bonus
Workplace Type
This is a hybrid position in Boston,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.