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.

• 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.

• Strong knowledge of…