Job Information
Actalent Clinical Trial Manager in Durham, North Carolina
The Clinical Trial Manager leads end-to-end clinical study operations within a defined therapeutic area, with a strong focus on in-patient studies involving cardio-pulmonary bypass and biologic therapies. This role provides strategic and operational oversight of clinical trials, ensuring that all activities comply with ICH-GCP, applicable regulatory requirements, company SOPs, and study protocols. The Clinical Trial Manager drives performance of CROs and vendors, coordinates cross-functional teams, and safeguards data integrity, quality, timelines, and budget for assigned studies.
Responsibilities
Manage clinical trial studies within assigned therapeutic areas, including in-patient studies and cardio-pulmonary bypass and biologics programs, ensuring full compliance with GCP/ICH guidelines, regulatory requirements, company SOPs, and study protocols.
Provide day-to-day leadership, guidance, and oversight to internal and external project team members, including CRO staff, vendors, investigators, and study coordinators, to ensure high-quality study execution.
Oversee third-party vendors, including CROs and other service providers, and develop and coordinate responses to vendor audits.
Evaluate vendor performance proactively, identify potential issues early, and develop and implement effective corrective and preventive action plans.
Provide clinical input and/or develop key clinical and regulatory documents such as study protocols, investigator brochures, and clinical study reports for submission to regulatory authorities.
Lead the overall planning and execution of investigator meetings, ensuring appropriate content, logistics, and alignment with study objectives.
Develop detailed study-specific timelines and align them with broader program timelines, actively managing risks and mitigations to support on-time milestone achievement.
Ensure internal functional areas complete their deliverables on time to support issue resolution and achievement of study milestones.
Coordinate the effective communication of study information to data management, safety, regulatory, and other functional or departmental groups.
Contribute to and maintain study-specific clinical risk and opportunity registries, including identification of risks and opportunities and development of contingency and mitigation plans.
Partner closely with Biometry and Data Management to develop robust case report forms, data management plans, data transfer plans, and data cleaning and reconciliation strategies, and coordinate clinical review of data listings.
Collaborate with the Manager of Supplies to ensure timely manufacturing, packaging, labeling, and shipping of clinical supplies in accordance with regulatory and country-specific requirements.
Work closely with the Manager of Contracts to develop and contribute to study budgets, RFPs, and investigator budget templates, and actively participate in and drive the vendor selection process.
Manage and lead regular meetings with CROs, vendors, and cross-functional teams to ensure quality, budget adherence, and timely delivery of all study-related activities.
Review site and vendor invoices to confirm that project expenses align with work performed and contracted terms.
Ensure appropriate training is developed and delivered for internal staff, CRO staff, vendors, investigators, and study coordinators on study requirements, therapeutic indications, and operational processes.
Take overall responsibility for resolving escalated study conduct issues from study centers, regulatory authorities, and IRBs/ECs, ensuring appropriate mitigation and follow-up.
Review escalated issues from study managers and CRAs, including investigational site monitoring findings and site audit reports, and ensure that adequate mitigation and corrective action plans are implemented.
Draft, review, and approve critical study documents, including informed consent forms, site worksheets, vendor and site manuals, pharmacy manuals, and central laboratory manuals, as needed.
Oversee CTMS tracking to support the evaluation, set-up, conduct, and follow-up activities of clinical studies, ensuring accurate and timely data entry and reporting.
Monitor adherence to regulatory and essential document collection processes and oversee the timely release of clinical supplies to study sites.
Manage the trial master file (TMF) process, including ongoing maintenance, accurate filing, and administration of the TMF quality control plan.
Review tables, listings, and EDC data to ensure data integrity, identify trends, and support data-driven decision making throughout the study lifecycle.
Promote a culture of quality, transparency, and collaboration across clinical, scientific, and operational teams to support successful delivery of life-saving therapies.
Additional Skills & Qualifications
Experience working with biologics and plasma-based or advanced biopharma technologies.
Experience in cardio-pulmonary bypass or related in-patient therapeutic areas.
Experience working within both sponsor and CRO environments, providing insight into expectations and operational models on both sides.
Work Environment
The position follows a Monday through Friday schedule from 8:00 a.m. to 4:30 p.m., including a 30-minute lunch break. The standard arrangement is a hybrid model with three days onsite and two days remote each week, with the possibility of fully remote work for exceptionally strong candidates based on business needs.
Job Type & Location
This is a Contract position based out of Durham, NC.
Pay and Benefits
The pay range for this position is $57.00 - $71.32/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 Durham,NC.
Application Deadline
This position is anticipated to close on Apr 24, 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.