Senior Manager, Clinical Operations

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

 

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

 

Position Overview:

The Sr. Manager, Clinical Operations plays a key role to the success of Convatec’s clinical trials. The Sr. Manager, Clinical Operations oversees the management of the day-to-day operations of clinical trials, ensuring they are conducted efficiently, effectively, and in compliance with all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Convatec‘s policies and SOPs.

Key Responsibilities:

• Working closely with Clinical Study Managers (CSMs) and Clinical Research Associates (CRAs), manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance with applicable SOPs, guidelines, and regulations.
• Working closely with the Global Head of Clinical Operations, develop study level operational strategy and clinical operations plans in support of execution of the Clinical Portfolio.
• Working closely with CSMs, manage invoice and budget tracking for individual studies and provide input into budget forecasting activities.
• Support the selection, oversight, and management of Clinical Research Organizations (CROs) and other vendors for clinical studies that are outsourced to third party vendors (with the exception of data management / data analytics as this service would be managed by Convatec’s Manager, Data Management & Analytics.
• Monitor and assess vendor performance against contractual operational deliverables.
• Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors.
• Provide oversight of study scope, quality, timelines, and budget with the internal functional leads, CRO and vendors to ensure project objectives remain on track.
• Participate in a site engagement program to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities.
• Responsible for planning and conducting investigator meetings together with the CRO or Convatec meeting event planner.
• Partner with the CRO or lead CRA and CSM to ensure patient enrollment strategies are conducted effectively and on time.
• Participate in proactive data monitoring activities with the lead CRA to ensure quality and completeness of study data.
• Evaluate issues and suggest and implement solutions and mitigation as required.
• Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances.
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
• May independently manage Convatec clinical studies as needed.

Skills & Experience:

• Key competencies and characteristics candidates need to demonstrate to help build our diverse, inclusive culture and to be successful in this role include:
  • Strong clinical study management skills
  • Communication skills
  • Problem solving, conflict resolution, leadership and team building skills.
  • Excellent organizational and time management skills.