Clinical Affairs Specialist (Medical Devices) - Permanent - Chester area, UK - office based

Recruiter
SRG Clinical
Location
Cheshire
Posted
31 Jan 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Clinical Affairs Specialist (Medical Devices) Full-time, permanent, office based, Chester area SRG has partnered with an exceptional medical device company and a truly advanced opportunity has arisen as Clinical Affairs Specialist. Join a Global organisation with a robust product portfolio and a market leader in advanced wound care, ostomy care, continence and critical care and infusion devices. The Clinical Affairs Specialist will be coordinating and leading clinical activities on a project basis and it may include: Responsibility for any clinical investigations in line with pre and post market product launch requirements Clinical representation on New Product Development Core Teams Development of clinical evaluation plans and clinical evaluation reports Clinical input and expertise for change control activities, risk management activities complaint evaluations, Health Hazard Evaluation preparation, participating in project teams, reviewing Advertising and Promotional Materials Represent clinical affairs on project teams for product development and change control including risk assessments and Instruction-For-Use development Demonstrates a strong understanding of the overall device development program and Device Regulations Prepare and update Clinical Evaluation Reports including the preparation of systematic literature reviews, complaint analysis and overall analysis of clinical evidence Communicate and work closely with other departments to ensure timely completion of clinical documents for Regulatory filings and clinical responses to health authorities Provide medical review support for MRL approval for advertising and promotional material Coordinates and /or participates in the timely execution of a clinical investigation from a clinical study plan to final clinical study report within the established timeline and budget Supports the following activities including but not limited to: country and site selection, investigator meetings, CRF development, data review plan, database validations, data listing requirements and review, monitoring site start up, monitoring patient recruitment, preparation and /or review of appropriate clinical documents, Clinical Study Report development, CRF distribution, timely data collection, delivery of final database, etc. Competencies required: Minimum Bsc in Life Science degree, Allied Health, Pharmacy, or Nursing A full understanding of clinical trial process from study start up to database lock with a key understanding of timeline management Substantial device industry experience in clinical trial processes and management Strong understanding of clinical research, from Phase I – IV, including the protocol/project relationship and key milestones Understanding of the medical device industry and of the pre-clinical, clinical, marketing and regulatory components Ability to work to a high standard and ensures total compliance to ICH GCP, ISO 14155 and Company’s SOPs Can establish strong working relationships with clinical Investigators and key opinion leaders Seeks and welcomes feedback, responds to coaching, takes action to change Solid understanding of project planning and project management methods and the ability to apply them Excellent communication in English, both verbal and written Eligibility to work and live in the UK Training and development: Full on-boarding and training will be provided. HOW TO APPLY? Click on the "apply" button below. Alternatively for immediate consideration contact Mariusz Stokowacki on +44 (0)203 096 4703 or email mariusz.stokowacki@srg.co.uk SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of ‘Creating Tomorrow’s World’& helping patients world-wide. Our team at SRG Clinical also cover roles in Clinical Operations (CPM, CRA etc.), Biometrics (Statistics, SAS programming, Data Management), Medical information, Medical Affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 964 700. Key words: CRO, Pharma, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Medical Device, Permanent, Freelance, Contract, Part-time, Temporary, Clinical Research, Administrator, Assistant, CTA, Clinical Trial, Associate, Project Management, Senior, Manager, Career, Clinical Research Associates, CRA, SCRA, Clinical Monitoring, Site Monitor, Site Manager, CPM, Clinical Trial Manager, Study Director, Project Leader, Diagnostics, In-Vitro, IVD, Laboratory, Reagents, Non-interventional, Therapeutic Areas, Indication, Oncology, Respiratory, Cardiovascular, cardiology, Rheumatology, Diabetes, Ophthalmology, Dermatology, Urology, CNS, Neurology, haematology, orphan diseases, nephrology, musculoskeletal, endocrinology, gastroenterology, Recruitment, Wound, Skin, ostomy, Continence, Critical Care, Margin Improvement, Clinical Affairs, product launch, risk management, clinical research nurse,

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