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Title: Clinical Study Manager
Location: Durham, NC
Duration: 12+ Months
Description:
The Contract Clinical Study Manager provides operational leadership, coordination, and oversight for assigned clinical studies. This role supports the successful execution of study activities in accordance with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and study-specific plans. The Contract Clinical Study Manager works closely with internal cross-functional teams, CROs, vendors, investigators, and study site personnel to ensure study deliverables are completed with quality, within expected timelines, and in alignment with study objectives.
Primary Responsibilities
Provide day-to-day study management support and oversight for assigned clinical study activities from start-up through close-out.
Coordinate with internal project team members, CROs, vendors, investigators, and study coordinators to support milestone achievement and 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/or 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 contribution to RFPs, scopes of work, vendor budgets, and study/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.
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, including accurate filing, reconciliation, ongoing review, and execution of quality control activities.
Draft, review, and/or approve study-related documents, including informed consent forms, site worksheets, vendor/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.
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 study execution.
Prepare key reports on study progress, risks, issues, action items, and delegated clinical study management responsibilities.
Provide input into study, site, and vendor budgets, as needed.
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.
Managers and supervisors may assign other duties as needed.
Required Knowledge, Skills, and Abilities
Strong knowledge of clinical trial operations, study start-up, maintenance, and close-out activities.
Strong knowledge of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company SOPs.
Demonstrated 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, written, organizational, and interpersonal communication skills.
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.
Education and Experience
Bachelor's degree in a life science, health-related, or related field preferred; equivalent directly related experience may be considered.
At least eight years of clinical research experience, including 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 is required.
Experience in sponsor-side study management, vendor oversight, TMF management, audit/inspection readiness, and clinical study documentation is preferred.
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