Sr. Clinical Study Manager

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). To learn more about Convatec, please visit http://www.convatecgroup.com
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 Clinical Study Manager (CSM) and you’ll do the same.
The Clinical Study Manager (CSM) 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 Affaris (MACA), the CSM 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.

 

Key Responsibilities:

• Proactively manage assigned clinical studies.
• Support clinical study delivery across Clinical Study Management team.
• Identify and escalate clinical study risks; 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.
• Assist with 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 and manage study issues, resolve conflict and manage obstacles with general/limited oversight.
• Oversee 3rd party Vendors if 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.
• Involved in updating of processes and SOPs, with input on discussions around quality by design and operational delivery.
• May be assigned additional responsibilities to support projects/initiatives.
• Clear and sustained demonstration of Convatec's core values.

Skills & Experience:

• Good knowledge of the clinical study lifecycle.
• Clinical study management skills, including ability to manage timelines, budgets and resources effectively.
• Medical Device experience preferred.
• Keen attention to detail.
• Working knowledge of federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Collaborative team player.
• Experience in pre-market (IDE) studies preferred.
• Experience with Clinical Trial Management Systems preferred.

 

Qualifications/Education:

• Bachelor’s or equivalent degree required; preferably in life sciences, medicine, or related discipline.
• Minimum of 2-3 years Clinical Research experience, preferably within medical device arena, with at least 1-2 years of experience in clinical study management.
• Years of experience may be considered in lieu of education.

Travel Requirements:

Position may involve travel up to 20% of the time, mostly within US but overseas travel may be required. Most trips will include overnight travel.

Language Required:

• Speaking / Writing / Reading: Emglish

Working Conditions

Remote work environment however, travel to Lexington, MA office required.

Special Factors

Proficient working knowledge of Microsoft Suite including Office (Word/Excel/Powerpoint), Project, Teams

Flexibility to work across multiple timezones required.

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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will