Senior Manager, Clinical Operations

Convatec

114d

About The Position

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.

Requirements

• Bachelor degree in a scientific or health related discipline.
• Minimum of 8 to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials.
• Solid understanding of the device development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
• Demonstrated ability to lead teams in a fast-paced matrixed environment.
• Ability to successfully engage and work collaboratively with cross functional team members.
• Strong clinical study management skills.
• Excellent organizational and time management skills.
• Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements.

Nice To Haves

• Advanced scientific or business degree or equivalent experience desirable.
• Experience in wound care, ostomy, and/or incontinence is a plus.

Responsibilities

• 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.
• Develop study level operational strategy and clinical operations plans in support of execution of the Clinical Portfolio.
• 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.
• 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 internal functional leads, CRO and vendors.
• Participate in a site engagement program to build solid professional relationships with key opinion leaders and clinical site staff.
• Plan and conduct investigator meetings together with the CRO or Convatec meeting event planner.
• 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.
• 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.

Benefits

• Remote working options available.
• Opportunity for professional development.
• Dynamic and supportive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees