Clinical Trial Manager- Hybrid

About the role

This Contract Clinical Study Manager provides operational leadership, coordination, and oversight for assigned clinical studies from start-up through close-out. The role ensures that all study activities align with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and study-specific plans. The position works closely with cross-functional internal teams, CROs, vendors, investigators, and study site personnel to deliver high-quality results within agreed timelines and in alignment with study objectives, with a focus on leading phase 1 trials, clinical study teams, and vendor management.

Responsibilities

• Provide day-to-day management and operational oversight of assigned clinical studies from start-up through maintenance and close-out.
• Coordinate closely with internal project team members, CROs, vendors, investigators, and study coordinators to achieve 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.
• Lead and support regular meetings with CROs, vendors, and cross-functional teams to review study progress, risks, issues, action items, and deliverables.
• Track and support the development and maintenance of study-specific timelines, key deliverables, and mitigation plans to address delays or operational risks.
• Assist in vendor selection activities, including contributions 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 needed to address study-related issues.
• Coordinate and verify study-specific training for CRO staff, vendors, investigators, study coordinators, and other relevant 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/or 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 issues related to study conduct.
• Provide clinical and operational responses to study centers, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating issues when appropriate.
• Ensure that all study documentation supports inspection readiness and complies with applicable regulatory requirements, company SOPs, and study protocols.
• Oversee CTMS tracking and study status reporting to support the 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 closely with data management, safety, regulatory, clinical supplies, contracts, biostatistics, and other functional groups to support end-to-end study execution.
• Prepare clear and timely reports on study progress, risks, issues, action items, and delegated clinical study management responsibilities.
• Provide input into study, site, and vendor budgets and support financial planning as needed.
• Review site and vendor invoices to confirm that expenses align with work performed, approved budgets, and study agreements.
• Support development of investigator budget templates, vendor scopes of work, contract-related inputs, and study financial tracking activities.
• Perform additional related duties as assigned to support successful clinical study execution.

Requirements

• Strong knowledge of clinical trial operations, including study start-up, maintenance, and close-out activities.
• Strong knowledge of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company SOPs.
• Demonstrated experience leading phase 1 clinical trials within the past 3 years.
• Demonstrated experience leading a clinical study team within the past 3 years.
• Demonstrated experience managing vendors, including CROs, within the past 3 years.
• Proven ability to manage CROs, vendors, 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 communicate effectively with internal and external stakeholders.
• Strong organizational and interpersonal skills, with the ability to manage competing priorities and work independently.
• 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.
• At least two years of experience in clinical study management, clinical operations, or related clinical trial roles.
• Experience working with CROs, vendors, clinical sites, and cross-functional study teams.

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.
• Experience in TMF management, audit and inspection readiness, and clinical study documentation is preferred.
• Experience contributing to RFPs, scopes of work, vendor budgets, and study-specific planning documents.
• Experience reviewing clinical data, data listings, and vendor reports to support data integrity and GCP compliance.
• Comfort working in a hybrid environment and collaborating across clinical, scientific, and operational teams.
• Interest in mission-driven work supporting life-saving therapies and improving patient outcomes.
• Motivation to grow professionally through cross-functional projects and continuous learning.

Work Environment

This role follows a Monday through Friday first-shift schedule in a hybrid work model, with three days per week on-site in the Research Triangle Park (RTP) area. The position operates within a collaborative, innovation-driven environment that emphasizes cross-functional teamwork across clinical, scientific, and operational groups. The work involves regular use of clinical systems such as CTMS, eTMF, EDC, Microsoft Office, and study-specific tracking tools, as well as interaction with cutting-edge biopharma and plasma-based technologies. The site offers a blend of stability, growth, and purpose-driven work, with a strong culture of collaboration, transparency, and support for consultant contributions. The RTP location provides access to a vibrant biotech ecosystem, a strong talent network, and a high quality of life. Dress expectations align with a professional office and clinical operations setting appropriate for sponsor-side study management and interactions with internal and external stakeholders.

Pay

The pay range for this position is $57.00 - $71.32 per hour.

Benefits

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, and vision
• Critical Illness, Accident, and Hospital insurance
• 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)

Schedule

This is a hybrid position based in Cary, NC, with three days per week on-site in the Research Triangle Park (RTP) area. The role follows a Monday through Friday first-shift schedule.