Job Title - Clinical Affairs Manager Daily rate - up to £400 Location - Malmesbury Industry - Medical Devices 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.Contract / Malmesbury
My client, a global leader in Ophthalmic medical devices are seeking a synamic Account Manager with experience in the Ophthalmic sector. The role will suit an individual currently working in an Account Manager, Sales Manager or Business Development Manager role with experience in the Ophthalmic industry. Main responsibilities: Present and sell Ophthalmic Systems product range in surgical and out-patient fields in all areas and associated products to allow workplace solution. Full appropriate utilization, organization and accountability of demonstration equipment to facilitate product evaluation and convert sales opportunities in line with company policy Negotiation to agreed discount levels, seeking proper approvals to ensure profit/discount levels. Identify and develop sales prospects and other key accounts for innovative products Prepare customer presentations, tenders, and proposals. Be responsible for demonstration of equipment, liaison with EBME, Theatres and Supplies The timely follow up of all new leads and referrals resulting from field and marketing activity. Carry out defined sales action plans and schedules, as part of targeted marketing campaigns. Work with internal customers to facilitate delivery of customer orders/supply contracts and resolution of customer enquiries Coordinate supply contracts and provide customer training/product troubleshooting Project/Forecast the number of sales to be made (both capital and consumable) Develop and maintain product knowledge to defined standards of competency. Establish and maintain excellent customer relationships. Participate in marketing events such as exhibitions and workshops, maintaining professional conduct at all times. Identify and resolve customer concerns/complaints. Communicate new product and service opportunities, special developments, information, or feedback gathered through field activity to appropriate company staff. Prepare business plan to allow target achievement with review of territory/target objectives quarterly Maintain CRM database, Solutions pipeline, Market database to ensure key customer details are correct and known Maintain professional conduct, ensuring representation of the Company values and ethics at all times Experience required: Excellent communication skills Work as a team player Be able to work independently Act with integrity in relation to customers and work colleagues Proactive performance orientation with ability to develop and implement business plan for area Ability to develop relationship with KOLs, Theatre personnel, Surgeons, Clinical Educators, Nursing Staff, Business Managers , EBME,NHS Framework and Supplies Departments within the NHS and Private Sector University degree in a science or product related field or graduate from a higher institution, or equivalent. Proven sales record in Ophthalmic Surgical consumable and capital environment. Working knowledge and understanding of theatre environment Ability to develop strong relationships with all levels of staff within a NHS or Private Hospitals quickly Please apply as soon as possible to be considered for this exciting Account Manager opportunity with a world class organisation. 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 Recruitment are those of an Employment Agency.Permanent / Manchester
We have been more than encouraged by the work that Jonathan Lee Recruitment has completed for the members of the EEF, their marketplace knowledge across a wide variety of engineering sectors and most importantly the strong professional culture that they work to and high levels of service they provide. We would happily recommend the Jonathan Lee Recruitment business to any engineering and manufacturing organisation looking to engage a professional, committed and quality consultancy to support their recruitment activities.
I would like to thank Jonathan Lee Recruitment for the fantastic assistance given to me along my recruitment path to find employment. The communication was great via e-mail and telephone. The guidance you gave was second to none relating to my CV and experience. I received the perfect job description matches from your systems job alerts which I duly successfully applied to. Thank you Jonathan Lee Recruitment...the perfect team!
I would like to thank Jonathan Lee Recruitment for their patience and professionalism in helping me secure my new role. They supported me throughout my application and even coached me before my interviews. I even had good luck messages before my initial interview. They kept me well informed, returned all my calls and sought positive outcomes when required. I would not hesitate to recommend the team at Jonathan Lee Recruitment to anyone looking for a job.
I was contacted Jonathan Lee Recruitment, who guided me through the labyrinth of modern day recruitment. Keeping me fully informed and allaying my fears at every step of the process. Working with me to ensure I was fully prepared for every new encounter. The only company I found to give such a “full on” supporting role. Thanks to Jonathan Lee Recruitment. I was offered the role within 2 months of my initial application and will be continuing my career soon.
Since my first contact through to successfully securing a position via Jonathan Lee Recruitment, you have been really professional and understanding to my situation and tried to help me as much as possible. I have had a really good experience with Jonathan Lee Recruitment because of the work you have done on my behalf and I have no hesitation in recommending yourselves to my friends and colleagues. Thank You!