Job Title: Early Development Project Manager / Director
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Vacancy details
Vacancy description:
Job Code:
13570
Job Title:
Early Development Project Manager / Director
Job Category:
CRM (Clinical Research Management)
Contract:
Permanent
Discipline:
Clinical Director, Clinical Project Manager
Country:
United Kingdom
Location:
East Sussex
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 Jun 2008
This exciting opportunity has arisen within an innovative Pharma based in East Sussex that deals in novel antimicrobial products. They are seeking a candidate for the above position, which can be home based for candidates living in commuting distance of East Sussex and able to get into the company's office easily. Experience candidates are invited to apply, from a Clinical Trial / Project Manager to a Clinical Director level.
JOB ROLE: This hands on position requires a candidate with the strategic vision and direction to lead the project. Duties will combine running a Phase I-IIa trial together with the pre-clinical formulation side of studies. This could include management of chemical discovery, pre-clinical and CMC areas.
PRINCIPAL RESPONSBIITIES include:
�Managing relevant clinical trial activities, including IB, protocol writing and CRF development, site selection and drug release, recruitment and CRF data flow and ensuring compliance with all regulations, relevant SOPs and ICH GCP.
�Coordinating data submissions to relevant regulatory authorities.
�Coordinating pre-clinical testing and reporting thereof.
�Proposing, evaluating and making recommendations for the selection of contractors (manufacturing, trial management/monitoring, central labs etc).
�Providing key contact for CRO delegated responsibilities.
�Organising and leading regular project team meetings and facilitating the decision making process.
�Facilitating appropriate levels of communication between Development, other departments and company management.
�Communicating budgetary and financial aspects of studies to the Accounts Department.
�Working as a member of the Development Department to improve process continually.
�Disseminating study results, by writing and submitting papers and abstracts, presenting results, attending meetings, symposia and conferences etc.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
�Life Science Degree.
�Experience of planning and setting up clinical systems within a small / medium company.
�Experience in setting up investigator sites.
�Good early phase experience.
�Previous pre-clinical experience (management of chemical discovery, pre-clinical and CMC areas) is essential.
�UK experience ideally.
�Strong project management skills.
�Very hands on with experience in setting up clinical systems (running the study at a practical day to day level).
�Strategic clinical direction and vision
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors.
KEY WORDS: Early Development, Project Manager, Director, Biotech, Biotechnology, Clinical Trials, CRF Development, Regulatory Submissions, Pre-Clinical, Chemical Discovery, CMC, CRO Management, Clinical Development, Phase I-IIa, Life Sciences, Pharmaceutical,
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