Clinical Study Manager (537966)

The Contract Clinical Study Manager is responsible for providing operational leadership, coordination, and oversight of assigned clinical studies from study start-up through close-out. This role works collaboratively with internal cross‑functional teams, contract research organizations (CROs), vendors, investigators, and site personnel to ensure studies are executed efficiently, compliantly, and in alignment with clinical development objectives. The ideal candidate is a proactive clinical operations professional with strong expertise in study management, vendor oversight, risk management, and cross‑functional collaboration. The Clinical Study Manager will ensure study activities are conducted in accordance with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and project timelines while maintaining a strong focus on quality, compliance, and inspection readiness. Key Responsibilities Lead and oversee day‑to‑day operational activities for assigned clinical studies from initiation through close‑out. Coordinate study execution with internal stakeholders, CROs, vendors, investigators, and site personnel to ensure achievement of study milestones and deliverables. Monitor study start‑up activities, including essential document collection, site activation requirements, investigational product readiness, and study‑specific tracking processes. Facilitate and lead study team, vendor, and CRO meetings to review study progress, identify risks, track action items, and drive issue resolution. Develop, maintain, and monitor study timelines, deliverables, and risk mitigation plans to support successful study execution. Support vendor selection and contracting activities, including requests for proposal (RFPs), scope of work development, budget review, and vendor planning documentation. Oversee CRO and vendor performance, ensuring timely delivery of study services and proactive management of operational challenges. Identify, escalate, and support resolution of study risks, quality concerns, and performance issues through appropriate corrective and preventive action (CAPA) plans. Coordinate and document study‑specific training for CRO personnel, vendors, investigators, site staff, and internal study team members. Monitor vendor staff qualifications, training compliance, personnel changes, and performance against key study milestones and performance indicators. Support Trial Master File (TMF) management activities, including document filing, reconciliation, quality control reviews, and inspection readiness initiatives. Draft, review, and approve study‑related documentation, including informed consent forms, study manuals, monitoring plans, site tools, pharmacy manuals, laboratory manuals, and monitoring reports, as applicable. Review monitoring findings, audit observations, and other study conduct issues, ensuring appropriate follow‑up and resolution. Serve as a key operational contact for clinical sites, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating complex issues as needed. Ensure study records and processes are maintained in compliance with regulatory requirements, company procedures, and study‑specific plans. Oversee CTMS maintenance, study metrics, and status reporting to support effective management of study progress and performance. Review clinical data, monitoring trends, vendor outputs, and study reports to support data quality, integrity, and GCP compliance. Collaborate with Data Management, Biostatistics, Safety, Regulatory Affairs, Clinical Supply, Contracts, and other functional groups to ensure coordinated study execution. Provide input into case report form design, data management plans, data transfer specifications, and clinical data review activities. Prepare regular study status updates, risk assessments, operational reports, and executive summaries for internal stakeholders. Contribute to study, site, and vendor budget planning, forecasting, and financial oversight activities. Review site and vendor invoices to ensure expenses align with approved budgets, contracted services, and study agreements. Support development of investigator budget templates, vendor scopes of work, contract inputs, and study financial tracking processes. Participate in audit and inspection readiness activities by ensuring documentation, processes, and oversight activities are complete and inspection‑ready. Perform additional duties and responsibilities as assigned. Qualifications, Knowledge, Skills, and Abilities Strong knowledge of clinical trial operations, including study start‑up, conduct, maintenance, and close‑out activities. Thorough understanding of ICH/GCP guidelines, applicable regulatory requirements, and clinical research best practices. Demonstrated experience managing CROs, vendors, study timelines, budgets, risks, and cross‑functional deliverables. Strong problem‑solving skills with the ability to assess issues, recommend solutions, and drive timely resolution. Proven ability to prioritize multiple projects and manage competing deadlines in a fast‑paced environment. Excellent organizational, verbal, written, and interpersonal communication skills. Ability to work independently while effectively collaborating with internal and external stakeholders. Strong attention to detail and commitment to quality, compliance, and inspection readiness. Proficiency with clinical systems and software, including CTMS, eTMF, EDC platforms, Microsoft Office applications, and study tracking tools. Ability to analyze study metrics and operational data to support decision‑making and study oversight. Education & Experience Bachelor’s degree in Life Sciences, Nursing, Healthcare, or a related field preferred; equivalent clinical research experience may be considered. Minimum of eight (8) years of clinical research experience, including at least two (2) years in Clinical Study Management, Clinical Operations, or a similar study leadership role. Proven experience working with CROs, vendors, investigative sites, and cross‑functional clinical development teams. Experience in sponsor‑side clinical study management is strongly preferred. Experience with vendor oversight, TMF management, inspection readiness, audit support, and clinical trial documentation is highly desirable. Demonstrated success managing multiple stakeholders and delivering clinical studies on schedule and in compliance with regulatory and quality standards. Full‑time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits. At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact View email address on click.appcast.io. #J-18808-Ljbffr Advanced Clinical