Job Description

Medical

Senior Program Manager

Location:
Northampton
Salary:
£50,000 - £58,000 Per Annum
Job Requirements/Description
My Client are a global organistation and are searching Program Manager within there Metabolism team Purpose of the Role To programme manage packages of Metabolism studies and analytical project manage clinical metabolite profiling and identification studies. Roles and ResponsibilitiesStudy Management * Act as Analytical Project Manager on clinical metabolite profiling and identification studies. * Prepare analytical work plans, study reports and SOPs as required. * Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan. * Work closely with clinical site and client to ensure requirements in terms of timelines are understood and can be met. Programme Management * Act as a link person between Business Development and Operations at the proposal stage for packages that will require Programme Management support. * Liaise with Business Development to raise supplementary proposals for scope changes/additional studies. * Manage programmes of studies for a client which extend across different Metabolism areas e.g. ADME, Clinical QRA, Metabolite ID & profiling, In Vitro & DDI and involve external organisations e.g. Clinics and Subcontractors. * Work with SDs/ the Metabolism Management Team to ensure all necessary pre-study information is obtained from the client and distributed * Communicate regularly with clients to ensure their expectations are understood, managed and met as appropriate. * Liaise with Chemistry on schedule for synthesis and delivery of radiochemicals for use on managed programmes. * Chair and circulate action points from regular telephone conferences with clients and relevant parties as required. * Ensure sponsors are kept informed of study progress and there is good communication between different areas of Metabolism and external organisations. * Compile regular programme status reports and send to clients. * Actively participate in and where necessary lead client facility. * Where appropriate advise clients of further available services which could help progress their programme.. As a recognised expert in a Metabolism; increase the profile of the department externally through playing an active role in expert groups, networking and publications.General Responsibilities * Comply at all times with Health & Safety legislation and Company Safety Policies. Ensure that any defect which may affect safety at work is brought to the attention of Management. * Comply with Good Laboratory Practice, Good Clinical Practice and/or Good Manufacturing Practice requirements whenever appropriate to the work being undertaken. * Comply at all times with company Standard Operating Procedures unless specifically varied in the study plan. * Comply with Study Plans. * Ensure that Personal Training File is up to date at all times. * Respect the confidentiality of information obtained in the course of duties performed and refrain from disclosing such information without written consent from management, except where disclosure is required by law or by the order of a Court. QualificationsEssential: PhD, MSc or BSc (Hons) in Chemistry, Biochemistry , Biomedical Sciences or related subject ExperienceEssential: * Many years' experience in Metabolism in a CRO, or Pharmaceutical company * Experienced Study Director/Analytical Project Manager in a GLP facility Knowledge and SkillsEssential: * Recognised Metabolism expert * Project Management * Scientific data interpretation, reporting and presentation skills * Understanding of the drug development process * Good knowledge of Microsoft Office software * Coaching & Mentoring * Proficiency in analytical techniques (HPLC/TLC/LC-MS)
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