Company: CK Clinical
Closing Date: 09 Dec 16
Salary (£): Negotiable
Charlene Dutchman is currently recruiting for a Clinical Study Manager to join a Medical Devices company based in Warwickshire, on a full time, permanent basis. ...
Charlene Dutchman is currently recruiting for a Clinical Study Manager to join a Medical Devices company based in Warwickshire, on a full time, permanent basis.
Our client has developed advanced haemodialysis systems, for use in the home and clinic, providing clinical efficacy.
This role involves all aspects of clinical research and medical communications, and is critical to the ongoing evolution of our Haemodialysis product. The successful candidate will be responsible for the entire lifecycle of our clinical programmes, from concept and design through to implementation and reporting, including creating clinical SOP's and writing clinical protocols.
As Clinical Study Manager, your responsibilities will include the following:
- Overall responsibility for clinical strategy including clinical operations, medical affairs and medical communications, with a focus on clinical and marketing trials.
- Ensuring compliance with all relevant regulatory requirements in cooperation with QARA and protocol set by the Company.
- Working with Finance, Operations, QARA and Sales to develop budgets, forecast schedules and adequate, maintained devices for clinical activities to meet the strategic goals of the Company.
- Working with QARA to prepare documentation for submissions to obtain approval for legal market distribution of medical devices, supporting regulatory inspections/audits and ensuring deadlines are met.
- Develop and implement clinical marketing plan, serving as a senior relationship manager and spokesperson in clinical marketing and outreach activities.
- Maintaining up to date knowledge of local and global medical device regulations.
- Reviewing, obtaining and providing clinical input on content of device labelling and promotional material.
- Contribute clinically towards company Training and Education; help develop, deliver and further improve company “Train the Trainer” internally and externally on topics like clinical protocol and dialysis outcomes.
- Developing and maintaining policies and procedures to support clinical study management, safety reporting mechanisms and that relevant documentation is maintained and archived.
- Generating and supporting the publication of appropriate papers, posters, presentations, in relevant medical and scientific journals and at medical/scientific congresses.
- Select and manage vendors to assist in necessary operational aspects of running clinical trials (as budget and resource allows).
- Ensure adequate access to clinical resources and expertise to provide general counsel, guidance to the Company on all clinical matters.
- Be a competent partner for and further strengthen and expand company Medical Advisory Board (MAB).
- Lead the ongoing review of clinical trial data (as needed), analysis and interpretation including the development of first interpretable results, clinical trial reports, publications and internal/ external presentations.
- Attend national and international nephrology and ESRD conferences and report back to the CCO the actual scientific, market and industry knowledge.
- Liaise with Healthcare Professionals, academics and KOL's within our industry to promote awareness of the product and mission of the Company.
- Work with Marketing to determine relevant projects and publications that promote the features and benefits of the system.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Science degree or other relevant degree or qualification (PhD an advantage)
- Prior exposure to clinical nephrology/dialysis a distinct advantage
- Proven clinical research management/leadership experience (preferably within a medical device company).
- Working knowledge of relevant European Medical Device Directives and international standards.
- Proven experience of managing clinical trials from planning, implementation and successful completion.
- Curious and inquisitive in nature; always looking for the next improvement with ideas to evolve what has been done.
- Hands-on, collaborative, innovative personality; demonstrates ownership and accountability for the department whilst building strong relationships with all internal stakeholders
- Medical writing and statistical analysis skills (proven experience of this is required)
- Excellent communication skills, both with internal departments and external stakeholders
- Computer literate (all MS Office packages as a minimum)
- Flexible for UK and EU travel as and when necessary
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37569 in all correspondence.
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