Clinical Manager, Medical Devices. - Employment, career opportunity in UK

Job Title:  Clinical Manager, Medical Devices.
Job Type    Permanent
Location    Hull, North East England, Uk
Start Date    01/01/2014
Duration    Permanent
Salary    Negotiable
Ref No    290540-VLS06


This is a global role providing expert Clinical strategic and operational input into the global development of one or more therapy areas of our client's portfolio in Medical Devices. Leading a team of Clinical Project Managers you will ensure clinical programmes / trials meet legal, regulatory and quality standards and are delivered on time and cost to meet commercial requirements. You will also act as a key contact and liaison point with the various internal and external experts and partners required to design and run an effective clinical trial programme / trials.
 
Your responsibilities will include:
Develop commercially-aligned global clinical strategies for specific area, working with Senior Clinical Manager and other internal and external experts to optimise chance of success, quality, speed and cost.
Clearly communicate risks, issues and alternatives at the planning phase.
Provide people management and leadership, building talent and expertise in the team through excellence in recruitment, training / development and organisation management.
Manage conflicting priorities within portfolio area to ensure that strategic planning receives sufficient attention, whilst also ensuring delivery of pipeline clinical trials / programmes.
Manage the clinical budget for the respective area and work with the CRO Manager to ensure appropriate CROs are selected and value for money obtained
Ensure operational excellence for relevant portfolio of clinical trials, delivering studies on time, cost and quality. Includes hands-on input to operational aspects as required.
To manage and lead major / highly complex trials directly if required by the Category.
To ensure highest professional and ethical standards in terms of all clinical activities and that all work in respective area meets GCP / regulatory, legal and quality standards.
Ensure effective oversight of SOPs and performance of Investigators and Contract Research Organisations appointed to conduct clinical studies.
Oversee the production of appropriate technical file or dossier sections for product development and dossier updates, ensuring integrity of scientific arguments through thorough review.
Development of Clinical lifecycle management strategies to generate 'new news' on existing products.
Identification and championing of new clinical methods, models and techniques relevant and advantageous to our products within the Category area.
To work alongside, advise and influence professional relations, Marketing, Regulatory, R&D, Supply and Global Quality, providing expert clinical advice and support to maximise commercial opportunities.

PROFESSIONAL QUALIFICATIONS / EXPERIENCE / ATTRIBUTES
Appropriate scientific &/or medical degree with broad clinical and consumer healthcare (or pharmaceutical) industry knowledge and experience.
Experience with recruitment, management and development of people.
Knowledge of international regulatory frameworks as they relate to clinical requirements for product registration.
Experience of working closely with commercial colleagues and strong understanding of corporate and operational business issues.
Proven ability to work under pressure without compromising on deliverables.
Strong understanding of marketing strategy, planning issues, budgeting, priority setting, project management.
Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define, evaluate and take risks.
Good leadership, motivational and interpersonal skills.
Excellent communication skills (English).
Global mind set, commercial understanding of corporate and operational business issues.
Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
Strong intellectual curiosity with an appetite for exploring new and previously uncharted territories and an openness to change and ability to think out of the box.
If you would like more information regarding this position or for a confidential discussion regarding your career please call Sue at Venn Life Sciences on 02392 556099 or email sue.spice@vlsworldwide.com.




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