Clinical Trial Manager

Job Title: Clinical Trial Managerufeff Manage clinical trial studies for specific therapeutic areas while providing guidance and oversight to internal and external project team members. Ensure successful management of study operations in accordance with GCP/ICH Guidelines, regulatory requirements, and company SOPs and protocols. Responsibilities + Oversee third-party vendors and develop responses to vendor audits. + Evaluate vendor performance and implement corrective action plans as needed. + Provide clinical input for regulatory documents such as protocols and clinical study reports. + Manage the planning of investigator meetings and develop study-specific timelines. + Ensure internal functional areas complete deliverables to support milestone achievement. + Communicate study information to data management, safety, and regulatory personnel. + Contribute to the study-specific clinical risks and opportunities registry. + Partner with Biometry to develop data management plans and coordinate clinical review. + Collaborate with the Manager of Supplies for timely manufacturing and shipping of supplies. + Work with the Manager of Contracts to develop study budgets and drive vendor selection. + Lead meetings with CROs, vendors, and multi-functional teams to ensure quality deliverables. + Review site and vendor invoices to ensure expenses align with work conducted. + Conduct training for staff, CRO staff, vendors, and study coordinators on study requirements. + Resolve escalated study conduct issues from study centers and regulatory authorities. + Draft, review, and approve study documents including informed consent and site manuals. + Oversee CTMS tracking to support clinical study management. + Monitor adherence to regulatory document collection and clinical supplies release. + Manage the trial master file process, ensuring accurate filing and QC plan adherence. + Review data to ensure integrity and identify trends. Essential Skills + Clinical trial management experience. + Understanding of ICH GCP guidelines. + Vendor management expertise. + Project management skills. + Experience with in-patient studies, cardio-pulmonary bypass, and biologics. + Recent project management experience with Sponsors and CROs. + Ability to drive a CRO to deliver. Additional Skills & Qualifications + Experience in developing and managing study timelines. + Ability to oversee investigator meetings and manage study information flow. + Skill in risk identification and mitigation. + Ability to work effectively with cross-functional teams. + Competency in developing and reviewing study budgets and invoices. + Experience in managing trial master file processes. + Familiarity with CTMS tracking systems and data management plans. Work Environment The work schedule is Monday-Friday from 8:00 AM to 4:30 PM with a 30-minute lunch break. The role requires three days onsite and two days remote work each week. Remote candidates will be considered if they are an exceptionally strong fit. The work environment offers a collaborative, innovation-driven setting with exposure to advanced biopharma and plasma-based technologies. Located in Durham, the site provides stability, growth, and access to the Research Triangle's biotech ecosystem. 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 1, 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, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with 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 .

Created: 2026-03-26