Cordis has stood apart as a global leader in breakthrough cardiovascular and endovascular solutions for over half a century. Today, we are on a new journey—one where we are empowered to steer our way forward together as an independent company. Driven by our mission and guided by our values to impact millions of lives and broaden access to life-saving technology in over 65 countries. We take immense pride in having such purposeful work that saves lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. We strive to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
Clinical Study Manager
Location
United States
Posted
11 days ago
Salary
$115.0K - $165K / year
Seniority
Lead
No structured requirement data.
Job Description
Clinical Study Manager
Cordis
Role Description 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 - 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. Requirements - 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. Benefits - Remote-based working conditions. - 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.
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