Note: The job is a remote job and is open to candidates in USA. Cordis, in partnership with Selution, specializes in the development of advanced drug device combination products for treating coronary and peripheral artery disease. The Clinical Study Manager is responsible for the operational management and execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with regulatory standards.
Responsibilities
- Lead and manage all operational aspects of assigned clinical studies to ensure successful execution according to protocol, timelines, and GCP/ISO 14155 requirements
- Develop and maintain study project plans, timelines, and risk assessments
- Manage site selection, feasibility assessments, and initiation activities in collaboration with CRAs and regional teams
- Oversee vendor selection, contracting, and performance management for CROs, laboratories, imaging providers, and other external partners
- Ensure study budgets are tracked and variances are addressed proactively
- Prepare and maintain essential study documents, ensuring audit readiness and alignment with eTMF standards
- Monitor enrollment, data quality, and protocol compliance; implement mitigation strategies as needed
- Conduct cross-functional team meetings and maintain effective communication among study stakeholders
- Support development and review of study protocols, case report forms (CRFs), monitoring plans, and study reports
- Lead preparation for audits and regulatory inspections related to assigned studies
- Mentor and provide guidance to junior team members, including CTAs and CRAs
- Contributes to the continuous improvement of clinical operations processes and tools
Skills
- Bachelor's degree in Life Sciences, Nursing, or related field
- 8+ years of experience in clinical research, including at least 2 years in study management
- Strong knowledge of ICH-GCP, ISO 14155, and FDA regulations
- Proven ability to manage cross-functional teams and multiple global vendors
- Excellent organizational, communication, and leadership skills
- Experience managing cardiovascular or combination product clinical trials
- Prior experience with IDE and PMA submissions
- Familiarity with risk-based monitoring, EDC, eTMF, and CTMS systems
- PMP certification or equivalent project management training
Company Overview
From the first guidewire to the first drug eluting stent, for over 60 years Cordis has remained at the heart of cardiovascular innovation. It was founded in 1959, and is headquartered in Miami Lakes, Florida, USA, with a workforce of 1001-5000 employees. Its website is http://www.cordis.com.