Position Overview:
The Clinical Study Manager (CSM) is responsible for the planning, execution, and oversight of clinical investigations for medical devices across the product lifecycle, including pre-market and post-market studies. The CSM ensures that clinical studies are conducted in compliance with applicable regulatory requirements, including ISO 14155, FDA regulations, EU MDR, and Good Clinical Practice (GCP).
This role serves as the operational lead for assigned studies and as a primary point of contact for study timelines, budgets, site performance, vendors, and data integrity. The CSM collaborates closely with cross-functional partners including Regulatory Affairs, Quality, Medical Affairs, and Product Development to generate high-quality clinical evidence that supports product safety, performance, and regulatory objectives.
Candidates must have prior experience working directly for a medical device company.
What you will do:
Study Planning & Execution- Lead the planning, design, and execution of clinical studies (IDE, post-market, PMCF, registries, and observational studies) in alignment with business and regulatory strategy.
- Manages and oversee all aspects of clinical research projects.
- Ensure projects are timely, are evaluating accurate data, and are producing precise results.
- Plans, directs, creates, and communicates the study timeline.
- Develops detailed project plans, and monitors project milestones against performance indicators.
- Ensures the project is planned and conducted in accordance with all applicable regulations, standard operating procedures, and good clinical practices (GCP).
- Manages risk assessment and mitigation.
- Generates 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.
- Provide guidance, training, and operational oversight to Clinical Research Associates (CRAs) and other study team members, as applicable
- Contribute to continuous improvement of clinical operations processes, procedures, and best
Skills for Success:
Required education and experience- Bachelor's degree in Life Sciences, Engineering, or a related field required.
- Master's degree or PhD preferred.
- 3+ years of experience in clinical research.
- 2+ years in medical device study management required.
- Demonstrated experience managing pre-market and/or post-market medical device clinical studies.
- Hands-on experience with site start-up, enrollment management, monitoring oversight, and CRO management.
Preferred Education and experience- Certification through a professional organization such as ACRP or SOCRA.
- Experience working with interventional or procedural studies (IR, vascular, cardiology preferred)
Knowledge & Technical Skills- Strong knowledge of ISO 14155, FDA regulations, EU MDR, and GCP.
- Proficiency with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Trial Master Files (eTMF).
- Working knowledge of medical device quality systems and clinical documentation requirements
Core Competencies- Strong project management, organizational, and risk-management skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced, cross-functional environment.
- Demonstrated leadership and problem-solving capabilities.
Physical demands & Travel required - Ability to travel to clinical sites and industry meetings as required (up to 40%).
