Clinical Study Manager

Clinical Study Manager (Contract)

Location: Durham, NC 27709

Schedule: Monday-Friday, 8:00 AM-5:00 PM

Work Arrangement: Hybrid (3 days onsite)

Pay Rate: $56.99-$71.32/hour



Position Overview
We are seeking an experienced Clinical Study Manager to provide operational leadership, coordination, and oversight for assigned clinical studies from start-up through close-out. This contract role partners with cross-functional teams, CROs, vendors, investigators, and study sites to ensure studies are conducted in compliance with ICH/GCP guidelines, regulatory requirements, company SOPs, and study protocols while meeting quality, timeline, and budget objectives.

Responsibilities

• Manage day-to-day clinical study activities from study start-up through close-out.
• Coordinate with internal teams, CROs, vendors, investigators, and study coordinators to achieve study milestones.
• Oversee essential document collection, site activation, clinical supply release, and study tracking tools.
• Lead or support meetings with CROs, vendors, and cross-functional teams to review study progress, risks, timelines, and action items.
• Develop and monitor study timelines, deliverables, and mitigation plans for operational risks and delays.
• Participate in vendor selection, including RFPs, scopes of work, budgets, and planning documents.
• Monitor CRO and vendor performance and implement corrective and preventive action (CAPA) plans as needed.
• Coordinate study-specific training for CRO personnel, vendors, investigators, and site staff.
• Oversee vendor qualifications, training records, staffing changes, and performance against study milestones and KPIs.
• Manage and maintain the Trial Master File (TMF/eTMF), including reconciliation, quality control, and inspection readiness.
• Draft, review, and approve study documentation, including informed consent forms, monitoring plans, site worksheets, pharmacy manuals, laboratory manuals, vendor manuals, and monitoring reports.
• Review monitoring findings, audit observations, and study issues, ensuring timely resolution.
• Respond to questions from study sites, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating issues when appropriate.
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, company SOPs, and study protocols.
• Oversee CTMS tracking, study status reporting, and operational metrics.
• Review clinical data, vendor reports, monitoring trends, and data listings to support data integrity and GCP compliance.
• Collaborate with Data Management, Safety, Regulatory, Clinical Supplies, Contracts, and Biostatistics teams.
• Prepare study progress reports, risk assessments, and operational updates.
• ssist with study, site, and vendor budgets, invoice review, financial tracking, and contract-related activities.
• Perform other duties as assigned.

Qualifications

Required

• Bachelor's degree in Life Sciences, Health Sciences, or a related field, or equivalent directly related experience.
• Minimum of 8 years of clinical research experience .
• t least 2 years of experience in Clinical Study Management, Clinical Operations, or a related clinical trial role .
• Experience working with CROs, vendors, clinical sites, and cross-functional study teams.
• Strong knowledge of clinical trial operations, including study start-up, maintenance, and close-out.
• Thorough understanding of ICH/GCP guidelines, regulatory requirements, study protocols, and SOPs.
• Demonstrated ability to manage study timelines, vendor performance, operational risks, and competing priorities.
• Strong organizational, communication, and problem-solving skills.
• Experience using CTMS, eTMF, EDC, Microsoft Office, and other clinical trial management systems.

Preferred

• Sponsor-side clinical study management experience.
• Experience with vendor oversight, TMF management, audit and inspection readiness, and clinical study documentation.
• Experience supporting study budgets, contracts, and financial tracking.

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

ll qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.