Job Title - Clinical Affairs Manager
Daily rate - up to £400
Location - Malmesbury
Industry - Medical Devices
It is possible that this role will last beyond April 6th 2020, when reforms to IR35 tax legislation come into effect. As a result, the role will be assessed to determine if it falls inside or outside IR35.
An exciting opportunity has arisen with an innovative forward thinking company for a Clinical Affairs Manager. As Clinical Affairs Manager, you will be "hands on" and fully involved in all aspects of clinical research for medical devices. The clinical affairs manager will be responsible for the entire lifecycle of all clinical projects, from concept and design through to regulatory submissions, implementation and reporting. The role includes the creation of clinical SOPs, and writing clinical protocols.
Key Responsibilities of the Clinical Affairs Manager:
- Overall responsibility for setting the clinical strategy including clinical operations, with a focus on clinical investigations and evaluations for regulatory purposes and marketing trials.
- Responsible for interfacing with ethics committees and obtaining applicable ethics approval for proposed studies.
- Ensuring compliance with all relevant regulatory requirements in cooperation with Quality and Regulatory Affairs, the legal department and any relevant protocols set by the company.
- Develop budgets, forecast and planning schedules for the clinical affairs function.
- Provide adequate, maintained devices for clinical activities to meet the strategic goals of the Company.
- Work with Quality, Regulatory and Compliance departments to prepare documentation for submissions to obtain regulatory approval for commercialization of medical devices, supporting regulatory inspections/audits.
- Develop and implement clinical marketing plans, serving as a senior relationship manager and spokesperson in clinical marketing and outreach activities.
- Reviewing, obtaining and providing clinical input on content of device labelling and promotional material.
- Select and manage vendors to assist in necessary operational aspects of running clinicals as budget and resources permit.
- Lead the ongoing review of clinical trial data (as needed), analysis and interpretation including the development of first interpretable results, clinical investigation and evaluation reports, publications and internal/external presentations. Including post market follow up studies.
In addition to the above, you will have a Science degree and proven experience in the medical device sector and a working knowledge of IVD Directives, MDR and IVDr regulations, and other relevant international standards and guidelines. You will also have experience of Quality Management Systems ISO 13485. You will have proven experience of managing clinical investigations and evaluations from planning, obtaining ethics committee approvals, implementation and successful completion. Medical writing and statistical analysis skills advantageous. Knowledge of consumer products beneficial.
If you would like to know more about this role, please contact Sarah Gilbert at Jonathan Lee Recruitment.
Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Contracts are those of an Employment Business.