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