Clinical Study Manager
Overview
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.
Responsibilities
The Clinical Study Manager (CSM) is responsible for the operational management and execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with regulatory, ethical, and company standards. The CSM provides leadership to cross-functional teams and oversees all operational aspects of assigned studies, from start-up through close-out. This role works collaboratively with internal stakeholders and external partners, including CROs, vendors, and investigational sites, to ensure the highest quality and integrity of clinical data in support of regulatory submissions and business objectives.
Key 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.
Qualifications
Required Qualifications: 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. Preferred Qualifications: 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. Key Competencies Strategic and proactive project leadership. Excellent interpersonal and cross-functional collaboration skills. Strong analytical and problem-solving capabilities. Effective budget management and financial accountability. Adaptability and focus under dynamic, fast-paced conditions. Working Conditions Remote-based Occasional domestic and international travel for investigator meetings, site visits, or audits. Must comply with all company, regulatory, and EHS requirements. Pay / Compensation The expected pre-tax pay rate for this position is $114,950 - $165,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.