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Senior Clinical Project Manager
4 months ago
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 on our journey to #ForeverCaring as a Clinical Study Management Specialist, and you’ll do the same.
About the Role:
Provide operational expertise to ensure effective delivery of clinical studies across Convatec’s Business Units. Reporting to Head Global Clinical Operations, this role is key representative for Study Management team. Provide leadership and direction to team of Clinical Study Managers across lifecycle of a study in additon to delivering your own study portfolio.
Medical Device experience required.
Demonstrated track record in oversight of all clinical study operational aspects including: budgets, timelines, resources, CRO/vendor selection. Oversee clinical team staff during study start-up, routine monitoring and closeout activities, demonstrating enthusiasm and innovation. Ensure clinical study delivery in accordance with Convatec’s policies and procedures, ISO, FDA and local regulations.
Key responsibilities and authority:
Proactively manage assigned clinical studies. Support clinical study delivery across Clinical Study Management team. 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. Manage and follow clinical study activities through ongoing tracking and review of study progress. Provide input and report progress. 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. Work closely with other functional groups within Convatec’s Clinical Operations team such as Data Analytics, Site Management, QA and Biostatistics to support milestone achievement and manage study issues, resolve conflict and manage obstacles. Manages 3rd party Vendors 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. Support adoption of best practices, and updating processes and SOPs. Provide onboarding and line management of Clinical Study Managers. Travel Requirements up to 25%.Education:
Bachelor’s or Master’s degree required, prefer Life Sciences, Medicine, or related discipline. Minimum 7 years clinical research experience, strongly preferred within medical device arena; min 4 years experience in clinical study management. Prior line management experience preferred.Qualifications:
Strong project management skills, including the ability to manage timelines, budgets and resources effectively. Keen attention to detail. Excellent collaborative team player. Medical Device experience essential. Previous line management experience preferred. Experience in pre-market (IDE) and post-market clinical studies. Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs). Fluent verbal and written English essential. Multilingual (Spanish) is a plus. Willingness to travel domestically with some International.Working Conditions:
Hybrid working 1 day per week in the office driven by business requirements as Convatec has a flexible approach to office working .
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
#LI-MH1
#LI-Hybrid
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
