Clinical Study Manager

About the role

The Clinical Study Manager provides onsite operational oversight for assigned clinical studies from start-up through close-out, ensuring delivery aligns with ICH/GCP, regulatory requirements, and internal SOPs. This role partners with cross-functional teams, CROs/vendors, and study sites to drive timelines, manage risks/issues, and maintain inspection-ready documentation using tools such as CTMS/eTMF/EDC.

Responsibilities

• Provide day-to-day study management support and oversight for assigned clinical study activities from start-up through close-out.
• Cook up with internal project team members, CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities.
• Maintain 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.
• Aid 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.
• Aid 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.

Requirements

• 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.
• 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 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.