Clinical Trial Manager- Hybrid

Job Title: Contract Clinical Study Manager Job Description The Contract Clinical Study Manager provides operational leadership, coordination, and oversight for assigned clinical studies from start-up through close-out. This role ensures that all study activities are executed in accordance with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and study‑specific plans. The position involves close collaboration with internal cross‑functional teams, CROs, vendors, investigators, and study site personnel to deliver high-quality results within agreed timelines and in alignment with study objectives. Responsibilities Provide day‑to‑day study management support and oversight for assigned clinical studies from start‑up through maintenance and close‑out. Coordinate with internal project team members, CROs, vendors, investigators, and study coordinators to achieve key milestones and ensure timely delivery of study activities. Monitor adherence to essential document collection processes, site activation requirements, clinical supply release requirements, and study‑specific tracking tools. Support and lead meetings with CROs, vendors, and cross‑functional teams to review study progress, risks, issues, action items, and deliverables. Track and support development of study‑specific timelines, deliverables, and mitigation plans to address study delays or operational risks. Assist in vendor selection activities, including contributing to RFPs, scopes of work, vendor budgets, and study‑ or vendor‑specific planning documents. Evaluate CRO and vendor performance and support early identification, escalation, mitigation, and resolution of potential issues. Develop, implement, and follow up on corrective and preventive action plans, as appropriate, to maintain study quality and compliance. Coordinate and verify study‑specific training for CRO staff, vendors, investigators, study coordinators, and other relevant study team members. Support oversight of vendor staff qualification, training, turnover documentation, and ongoing performance against study milestones and KPIs. Assist in the management and maintenance of the Trial Master File (TMF), including accurate filing, reconciliation, ongoing review, and execution of quality control activities. Draft, review, and approve study‑related documents, such as informed consent forms, site worksheets, vendor and site manuals, pharmacy manuals, laboratory manuals, monitoring plans, and monitoring reports, as applicable. Review and support responses to site audits, monitoring findings, and other escalated study conduct issues to ensure timely and effective resolution. Provide clinical and operational responses to study centers, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating issues when appropriate. Ensure study documentation supports inspection readiness and compliance with applicable regulatory requirements, company SOPs, and study protocols. Oversee CTMS tracking and study status reporting to support evaluation and management of study set‑up, conduct, follow‑up, and close‑out activities. Review clinical data, data listings, vendor reports, monitoring trends, and other study outputs to support data integrity and GCP compliance. Provide clinical input into case report forms, data management plans, data transfer plans, and clinical data review activities. Collaborate with data management, safety, regulatory, clinical supplies, contracts, biostatistics, and other functional groups to support effective study execution. Prepare key reports on study progress, risks, issues, action items, and delegated clinical study management responsibilities for internal stakeholders. Provide input into study, site, and vendor budgets, as needed, to support financial planning and control. Review site and vendor invoices to ensure expenses are consistent with work performed, approved budgets, and study agreements. Support investigator budget templates, vendor scopes of work, contract‑related inputs, and study financial tracking activities. Perform other related duties as assigned to support successful delivery of clinical studies. Essential Skills Strong knowledge of clinical trial operations, including study start‑up, maintenance, and close‑out activities. Strong understanding of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company SOPs. Demonstrated ability to manage CROs and vendors, including oversight of study timelines, risks, action items, and cross‑functional deliverables. Ability to identify issues, evaluate options, make sound recommendations, and drive timely resolution. Strong verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders. Excellent organizational and interpersonal skills, with the ability to build effective working relationships. Ability to manage competing priorities, work independently, and collaborate effectively with internal and external stakeholders. Experience using clinical systems and tools such as CTMS, eTMF, EDC, Microsoft Office, and study‑specific tracking tools. At least eight years of clinical research experience, including a minimum of two years in clinical study management, clinical operations, or related clinical trial roles. Experience working with CROs, vendors, clinical sites, and cross‑functional study teams. Additional Skills & Qualifications Bachelor’s degree in a life science, health‑related, or related field is preferred; equivalent directly related experience may be considered. Experience in sponsor‑side study management and vendor oversight is preferred. Background in TMF management, audit and inspection readiness, and clinical study documentation is preferred. Strong project management capabilities, including planning, tracking, and reporting on complex clinical studies. Ability to work in a hybrid environment and maintain effective communication and coordination across onsite and remote teams. Interest in contributing to mission‑driven clinical research that supports life‑saving therapies and improves patient outcomes. Motivation to engage in continuous learning and professional growth through cross‑functional projects and exposure to advanced biopharma technologies. Work Environment This role operates in a hybrid work environment based in the Research Triangle Park (RTP) area, with a standard Monday through Friday, first‑shift schedule and an expectation of three days per week in the office. The position involves regular collaboration across clinical, scientific, and operational teams in a highly cross‑functional setting. The work is performed in modern, cutting‑edge facilities with exposure to advanced biopharma and plasma‑based technologies and the supporting clinical systems, including CTMS, eTMF, and EDC platforms. The culture emphasizes collaboration, transparency, and recognition of consultant contributions, offering opportunities to participate in mission‑driven work, expand skills through continuous learning, and engage with the broader biotech ecosystem of the Research Triangle region. Attire is typical of a professional office and clinical research environment. Job Type & Location This is a Contract position based out of Raleigh, 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 Raleigh, NC. Application Deadline This position is anticipated to close on Jul 20, 2026. 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 process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent