Job Description

Our clinical-stage startup medical device company is planning to execute two clinical studies to support a panel-track PMA device treatment for uncontrolled hypertension. The Sr. Clinical Study Manager will be responsible for executing these two randomized, double-blinded studies in collaboration with the Chief Clinical Officer. The Sr. CSM will collaborate with CROs to support the PMA approval of the Class III device and will be broadly accountable for the execution of the clinical study.

Your role with the company:

• Design and implement clinical study protocols, case report forms, and informed consent documents.
• Coordinate and oversee site administration, IRB, and subcommittee reviews, and ensure site training and administrative readiness are in place for site activation.
• Oversee all phases of clinical studies (pre-study through close-out), ensuring adherence to timelines, budgets, and regulatory requirements.
• Select and manage CROs and vendors, with particular focus on developing best practices learned from other device-based hypertension studies.
• Monitor study progress through metrics, site communications, and regular updates.
• Coordinate study-specific training for internal and external stakeholders.
• Ensure compliance with GCP and ISO 14155 throughout the study lifecycle.
• Prepare clinical study reports for submission to regulatory bodies.
• Engage with a cadre of physician consultants, including the clinical development steering committee, the DSMB, CEC, and other field consultants, by establishing agendas, leading meetings, and soliciting feedback and advice.

Regulatory & Quality

• Support regulatory submissions and provide clinical documentation to support regulatory submissions related to the clinical study.
• Support audits and inspections by regulatory authorities both within the company and at the clinical sites.
• Ensure accurate, timely, and compliant reporting of clinical study data.
• Contribute to the development of standard operating procedures for clinical studies.

Cross-Functional Collaboration

• Work closely with R&D, Regulatory, QA, Biostatistics, Marketing, and Medical Affairs teams.
• Participate in risk assessments, product development reviews, and design validation activities.

Data Oversight & Reporting

• Oversee data management and statistical analysis processes through the CRO.
• The clinical program requires very close surveillance of patient compliance with the protocol, and as a result, a key focus will be on establishing tools and metrics for, and regular monitoring of, patient compliance.
• Author, review and/or approve monitoring reports, data listings, and final clinical study reports (CSRs).
• Present study findings to internal stakeholders and contribute to publications and/or presentations.

Desired Profile:

• BS degree
• Minimum 5 years in clinical research, with 2+ years as a Clinical Study Manager with class III medical devices
• Experience in US pre-market medical device studies required; exposure to or experience with FDA panel review is preferred.
• Experience with global clinical study submissions and the presentation of data to regulatory authorities.
• Strong knowledge of GCP, ISO 14155, ICH guidelines, and FDA regulations.
• Excellent project management, problem-solving, and organizational skills.
• Effective communication and leadership skills.
• Proficiency with EDC systems, CTMS, and Microsoft Office.
• Familiarity with either hypertension or urologic interventional procedures is a plus
• Familiarity with risk-based monitoring and decentralized studies.
• up to 30% travel

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