Vacancy: Cambridge, United Kingdom
Clinical Development Manager
To meet the company’s growth plans, Endomag are seeking a highly capable Clinical Development Manager to ensure our products continue to uphold their world-class reputation.
This position plays a critical role for the business by managing Endomag’s clinical activities. You will lead on the day-to-day coordination and execution of clinical trials with external consultants and CRO’s and provide technical oversight of key clinical trial activities within the company.
Endomag conducts clinical studies of its surgical guidance products primarily in Europe and in the United States. These include Endomag-sponsored pre-market studies to support regulatory approvals and post-market studies to provide additional clinical data to support new indications or as mandated by regulatory authorities.
As part of a growth stage company, the Clinical Development Manager will often be tasked with all levels of clinical activities such as writing SOPs, writing protocols, developing CRFs, ICFs, etc as well as managing CRO’s and other vendors.
Vacancy Details
Key Responsibilities
- Develop and execute all clinical studies, per the clinical strategy, within agreed budgets and timelines
- Maintain study oversight and manage clinical personnel, primarily external CROs and consultants to enable effective execution of studies
- Maintain and develop key opinion leader relationships with Endomag’s network of high profile clinicians and trial sites in surgical oncology, and support investigator initiated studies
- Develop core clinical documents including protocols, informed consents, CRFs, study reports and SOPs
- Contribute to Endomag’s clinical processes and all studies are run to current legislations, standards and guidelines
- Ensure the clinical organization is audit-ready at all times
- Provide clinical input to regulatory submissions
- Develop and maintain global publication strategy to meet business needs
- Contribute to the writing of Clinical Evaluation Reports
- Maintain working knowledge of the clinical literature relevant to Endomag’s products e.g. breast surgical oncology
Requirements
- Bachelor’s degree or equivalent essential
- At least 5 years’ experience in clinical research and new product development
- Specific experience of medical device or drug/device combination product clinical trials. Oncology experience is helpful but not essential
- Specific experience managing CROs and third-party consultants
- Clinical project management experience of pre- and post-market clinical research, and investigator-initiated studies
- Knowledge of ICH-GCP and European medical device clinical trials regulations. Familiarity with other territories is beneficial e.g. United States, China
- Monitoring experience
Attributes and Behaviours
- Attitude – Self-starter with strong motivational skills and keenness to build positive relationships
- Communication – Be able to communicate clearly and effectively and demonstrate inter-personal skills.
- Attention to Detail – Evidence of ability to work with critical attention to detail and high levels of accuracy.
- Professionalism – Adhere to a high level of professionalism and integrity by demonstrating ethical behaviour and representing Endomag core values in all areas of the role.
- Planning/Scheduling – Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met.
- Teamwork – Work with others in contributing to the overall success of the company.
How to apply
Applications
To apply for this role, please email your CV/resume and a cover letter to: