Senior Clinical Study Manager

Job not on LinkedIn

🕒 April 9

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Convatec

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1978

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology

Convatec is a global medical products and technologies company focused on therapies for the management of chronic conditions. Convatec leads in advanced wound care, ostomy care, continence care, and infusion care. The company is known for its innovative solutions like Hydrofiber® Technology and FeelClean Technology™, which enhance patient outcomes by improving comfort and care in conditions such as stoma and wound management. With a holistic approach, Convatec offers products and support programs through platforms like me+, aiming to empower individuals to live confidently with their conditions.

📋 Description

• Proactively manage assigned clinical studies. • Ensure overall clinical study efficiency and adherence to project timelines and budget; report metrics to Head Global Clinical Operations as required. • Analyze and manage clinical study risks, propose solutions for risk mitigation. • Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans. • Coordinate production of key clinical study documentation including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF) and Clinical Study Report (CSR). • Motivate and manage a multi-disciplinary clinical study team. • Handle escalations for study management questions and issues for assigned projects. • Work closely with other functional groups within Convatec’s Clinical Operations team to support milestone achievement and manage study issues and obstacles. • Manage 3rd party clinical monitoring Vendors where necessary to support milestone achievement and to manage study issues and obstacles. • Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing. • Support audit and inspection activities as needed. • Support adoption of best practices, updating processes and SOPs.

🎯 Requirements

• Minimum of 5 years independently managing clinical trials is required. • Experience in the medical device industry and/or wound care, dermatology or related therapeutic areas is required. • Prior study management experience is required. • Comprehensive understanding on how to properly assess an investigative site's capabilities for conducting clinical research. • Knowledge of how to select and qualify an investigative site. • Ability to monitor and report on the progress of a clinical study from start-up to completion. • Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits. • Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).

🏖️ Benefits

• Equal employment opportunities for all current employees and applicants for employment.