Clinical Study Manager

What You Will Do

• Lead the planning, design, and execution of clinical studies (IDE, post-market, PMCF, registries, and observational studies) in alignment with business and regulatory strategy.
• Manage and oversee all aspects of clinical research projects.
• Ensure projects are timely, evaluating accurate data, and producing precise results.
• Plan, direct, create, and communicate the study timeline.
• Develop detailed project plans and monitor project milestones against performance indicators.
• Ensure the project is planned and conducted in accordance with all applicable regulations, standard operating procedures, and good clinical practices (GCP).
• Manage risk assessment and mitigation.
• Generate reports to provide periodic status updates.
• Develop, review, and manage clinical study documentation, including protocols, informed consent forms, case report forms (CRFs), statistical plans (as applicable), and clinical trial agreements.
• Serve as the primary operational lead for assigned studies from site selection through study closeout.

Site Management

• Coordinate site feasibility, selection, qualification, initiation, monitoring, and close-out activities.
• Provide oversight of site performance, enrollment, data quality, and protocol compliance.
• Support training and ongoing communication with investigators and site staff.

Regulatory & Compliance

• Ensure clinical investigations are conducted in accordance with ISO 14155, FDA regulations, EU MDR, and applicable international GCP requirements.
• Support regulatory submissions, audits, and inspections by maintaining inspection-ready Trial Master Files (TMF) and related clinical documentation.
• Collaborate with Regulatory Affairs to ensure alignment between study design, clinical evidence generation, and regulatory strategy.

Vendor & Budget Oversight

• Manage and oversee clinical research organizations (CROs), laboratories, and other vendors to ensure delivery of contracted services.
• Develop and manage study budgets, forecasts, and resource plans; monitor expenditures against approved budgets.
• Identify and mitigate operational, timeline, and budgetary risks.

Data & Project Management

• Track study milestones, timelines, and deliverables using clinical trial management tools.
• Monitor data quality and completeness; coordinate resolution of data queries and issues.
• Ensure accurate, timely reporting of study status, risks, and results to internal stakeholders.

Team Leadership & Collaboration

• Provide guidance, training, and operational oversight to Clinical Research Associates (CRAs) and other study team members, as applicable.