Sector: Life Sciences
Consultant: Stewart McGrath
Salary: £50000 - £60000
Job Status: Permanent / Full Time
Job Title: Clinical Affairs Manager
Salary: £50-60K Per Annum
Benefits: £500 a Month Car Allowance, 10% Bonus & Bupa Healthcare Plan
Key Purpose of The Role
Responsible for the lifecycle of clinical programmes, from concept and design through to implementation and reporting.
Fulfillment of the role shall ensure continued regulatory compliance and the provision of sufficient clinical data to enable ongoing certification of our devices.
Responsibilities of The Role
- Fulfilling the role of Sponsor as defined by ISO 14155
- Writing synopsis’ and protocols that align with clinical practices and follow up timelines to ensure that study progression is easily facilitated by investigators
- Obtaining ethics approval in a timely and efficient manner.
- Perform study monitoring to ensure that regulatory requirements are met
- Review, analyse and interpret clinical trial data
- Write clinical trial reports, and internal/external presentations
- Ensuring compliances with all relevant regulatory requirements in cooperation with Regulatory Affairs
- Developing and managing budgets for clinical activities to meet the strategic goals of the Company. ·
- Working with the Regulatory Affairs department to prepare documentation for submissions to obtain approval for legal market distribution of medical devices
- Supporting regulatory inspections/audits. ·
- Reviewing, obtaining and providing clinical input on content of device labelling and promotional material. ·
- Reviewing, obtaining and providing clinical input into Risk Management
- Reviewing, obtaining and providing clinical input into Clinical Evaluation Reports
- Reviewing, obtaining and providing Post Market Clinical Follow Up data
- Select, approve and manage vendors to assist in running clinical trials.
- Negotiate and agree contracts with vendors including Investigators to ensure regulatory compliance and to ensure responsibilities for Clinical Studies are defined
Qualifications & Experience
- Degree or other relevant degree or qualification (PhD an advantage). ·
- Proven clinical research management/leadership experience (preferably within a medical device company). ·
- Working knowledge of relevant European Medical Device Directives and international standards. ·
- Knowledge of the European Medical Device Regulation
- Working knowledge of ISO 14155
- Proven experience of managing pre market and post market clinical trials from planning and implementation to successful completion. ·
- Hands-on, collaborative, demonstrates ownership and accountability whilst building strong relationships with all internal and external stakeholders.
- Orthopaedic clinical experience would be desirable.
You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.
Are you ready for the challenge? If so, we look forward to hearing from you.
What else can you expect from Seven?
– Specialist Consultant allocated to you with all the expertise you require.
– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.
– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.
– £250 Referral Bonus for every person you successfully refer to Seven.
If you are interested in this opportunity, please call 020 3887 7365. Please ask for Stewart McGrath in the Life Sciences team.