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.

The Senior Clinical Study Manager (Sr. CSM) will provide leadership, direction, and oversight for a complex, multi-center patient registry within the MedAlliance LLC / Cordis SelutionSLR portfolio. This role manages study/registry team functions and external vendors to ensure successful execution of clinical trials from initiation through close-out, maintaining compliance with GCP, ISO 14155, GDPR, and all applicable regulatory requirements. The Sr. CSM serves as a key point of contact for global study/registry stakeholders, ensuring timelines, budgets, and quality objectives are met in support of clinical and regulatory milestones.

Responsibilities

• Lead the planning, initiation, and management of assigned registry duties across multiple regions.
• Develop and maintain project plans, risk management strategies, and timelines to ensure registry deliverables are achieved, following timely escalation pathways.
• Oversee vendor selection, contract negotiations, and ongoing performance management (CROs, Biostats, etc.).
• Support management of budgets, forecasts, and financial reconciliation processes.
• Ensure the preparation, review, and maintenance of essential documents and regulatory submissions in coordination with the CRO.
• Oversee site feasibility, selection, initiation, monitoring, and close-out activities in collaboration with CRAs and Field Research Specialists in coordination with the CRO.
• Track registry metrics and provide dashboards in collaboration with the CRO.
• Lead cross-functional global registry team meetings and maintain strong communication among stakeholders.
• Support the development and review of registry protocols, CRFs, and statistical analysis plans.
• Ensure the Sponsor / CRO are inspection-ready and compliant with internal and external standards.
• Clinical Data Handling to assist with abstracts, manuscripts, etc., for conference and publication submissions
• Contribute to continuous improvement initiatives and global clinical operations best practices, including mentorship and coaching of junior team members.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, or related field (or equivalent ed. & exp.).
• Minimum 12+ years of clinical research experience with at least 5 years in registry mgmt.
• Strong understanding of GCP, ISO 14155, GDPR, and FDA/EMA device regulations.
• Proven experience leading complex, multicenter patient registries.
• Excellent organizational, leadership, and cross-functional communication skills.

Preferred Qualifications:

• Experience with cardiovascular (Coronary is a plus) studies & PMA activities
• Familiarity with global regulatory requirements and submissions.
• Proficiency with eTMF, CTMS, and data management systems (EDC).
• Exposure to medical writing procedures and practices

Key Competencies

• Understanding registries, medical terminology, and data interpretation/outputs.
• Excellent decision-making, conflict resolution / problem-solving skills.
• Financial and resource management acumen.
• Accountability, adaptability, flexibility and results orientation with ability to operate with autonomy, balance multiple priorities, multi-task and escalate key challenges
  
  

Working Conditions

• Remote work environment with occasional travel for site visits, audits, or meetings.
• Must comply with all company, regulatory, and EHS standards.
  

Pay / Compensation
The expected pre-tax pay rate for this position is $139,700 - $200,200 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.