Sr. Clinical Study Manager - Device

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: 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, united by a promise to be forever caring. 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). To learn more please visit http://www.convatecgroup.com

 

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: 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, united by a promise to be forever caring. 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). To learn more please visit http://www.convatecgroup.com

 

About the role

This is a remote US-Based role, seeking someone residing in the Eastern Time Zone

Key Responsibilities:

• 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.

Authority (if applicable):

Ability to provide recommendations and suggestions to ensure delivery of assigned clinical study(s).

 

Skills & Experience:

• 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.

Qualifications/Education:

• 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.

Dimensions:

Principal Contacts & Purpose of Contact

Internal – Medical Affairs, Clinical Operations (Study Management, Site Management, Study Co-ordination, Data Analytics), Evidence Genertion, R&D

External – Vendors, Clinical Sites, Regulatory approvers (FDA, Competent Authorities, IRB/EC)

Travel Requirements

Position may involve travel up to 20% of the time, mostly domestic but some international travel may be required