[Hiring] Sr. Clinical Study Manager - Device @Convatec

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This is a remote US-Based role, seeking someone residing in the Eastern Time Zone. • Proactively manage assigned clinical studies. • Effectively manage clinical study delivery across the Clinical Study team during study start-up, routine monitoring, and closeout activities, demonstrating enthusiasm and innovation. • Identify and escalate clinical study risks and propose solutions for risk mitigation. • Oversee clinical study finance tracking, identify and escalate potential risks. • Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans. • Coordinate the production of key clinical study documentation, including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF) and Clinical Study Report (CSR). • Motivate a multi-disciplinary clinical study team. • Drive milestone achievement through management of study issues and conflict resolution with limited oversight. • Oversee 3rd party Vendors where necessary to support milestone achievement. • Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing. • Support audit and inspection activities as needed. • Update processes and SOPs, providing input in discussions around quality by design and operational delivery. • Demonstrate Convatec's core values. • May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives. Qualifications • Bachelor’s or Master’s degree required, preferably in life sciences, medicine, or related discipline. • Minimum of 10 years Clinical Research experience, preferably some within the medical device arena, with at least 5 years of experience in clinical study management. Years of experience may be considered in lieu of education. Requirements • Strong knowledge of the clinical study lifecycle. • Clinical study management skills, including the ability to manage timelines, budgets and resources effectively. • Medical Device experience essential. • Keen attention to detail. • Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs). • Excellent collaborative team player. • Experience in pre-market (IDE) and post-market clinical studies. • Experience with Clinical Trial Management Systems. Company Description Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. • With more than 10,000 colleagues, we provide our products and services in around 90 countries. • Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. • Convatec’s revenues in 2024 were over $2 billion. • The company is a constituent of the FTSE 100 Index (LSE:CTEC). Apply tot his job