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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).
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