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Reference No: J12807

Clinical Feasibility Leader
Location: Uxbridge

Clinical Professionals are currently working with a globally recognised Pharmaceutical company to recruit a Clinical Feasibility Leader to be based in their Uxbridge offices.

Essential Function
Provide feasibility assessments for new business opportunities or awarded studies including supervision of external investigator surveys and coordination of other support groups as required.
Develop operational strategies including scenario planning (country/site optimization) and support the preparation of bid defence meetings.

Provide expertise in the recruitment and selection of qualified investigators in support of the companies clinical projects by data mining their internal data assets and using external data if appropriate.

Working in close collaboration with local Clinical Trial Specialists staff in various countries. Contribute to strategies to improve the customer relationship with sites, including development of new models of collaboration.
Analyse and work to continuously improve predictive investigator performance metrics.

Key Accountabilities
• Perform feasibility assessment of clinical protocols to assess the operational impact by the protocol design, interpretation of past performance data and it’s relevance to the current protocol, coordinate the input from other expert groups (Medical Services, Study Start-Up, Regulatory Affairs and Patient Recruitment Strategy Group) into the feasibility assessment that is being delivered to the proposal writer.

• Develop recommendations for country allocation and site distribution inclusive of scenario planning by using the SPARC application.

• Develop feasibility and site selection slides with the support of Clinical Feasibility Specialist I in case of external survey for presentation at the bid defence meeting.

• Support the development of the proposals and costing for stand-alone Feasibility & Clinical Informatics services including proposal revisions as needed and contract review.
• Provide work instructions and guidance to Clinical Feasibility Specialist I & II and Clinical Informatics Specialists I & II for the conduct of questionnaire-based investigator surveys.
• Perform quality review of feasibility/pre-qualification questionnaires and related reports/slides presenting the survey results.

• Prepare site lists by using data mining of internal and external data assets, using the companies investigator performance data .

• Develop and support the implementation of site selection strategies in support of clinical projects in close collaboration with Clinical Trial Specialists in various countries and project teams.
• Develop and implement strategies for improving investigator relationship management including new ways to collaborate with investigators, SMOs and other investigator organizations.

• Analyse and work to continuously improve predictive investigator performance metrics in support of site selection.

• Assist in the development of programs to recruit and maintain a qualified pool of investigators in support of projects in all therapeutic areas.

Candidate requirements:

• Educated to a degree in Science, possibly in Life Sciences, or relevant qualification/experience

• Significant experience in clinical research within a Pharmaceutical or CRO including appropriate expertise in feasibility assessments and/or clinical monitoring study coordination and/or site and investigator relationships.

• The ideal profile is a Feasibility Manager, Clinical Project Manager or Data Management Manager with international experience (i.e. experience of managing trials across at least 5 countries).

If this role is of interest to you please do not delay in getting in touch today on the following details:

Catherine Kennedy: 01189594990 / ckennedy@clinicalprofessionals.co.uk

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