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 around 10,000 colleagues, we provide our products and services in almost 100 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. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). 

At Convatec we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us as a Senior Clinical Study Manager (SCSM) and you’ll do the same.

The Senior Clinical Study Manager (SCSM) provides operational expertise to ensure the effective and efficient delivery of assigned clinical studies. As part of the Clinical Study Management pillar of Clinical Operations, Medical Affairs & Clinical Affairs (MACA), the SCSM is key in the successful delivery of clinical studies to support evidence needs across Convatec’s Business Units. Reporting to the Clinical Study Management Specialist, this role will ensure clinical study execution is timely, cost-effective and in accordance with Convatec’s policies and procedures, ISO, FDA and local regulations.

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. Trips may include overnight travel.