About this role
Role Overview
- 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.