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Programme Manager

2 months ago

Rushden, Northamptonshire, United Kingdom Pharmaron Full time
Job Description

We are seeking a highly skilled Programme Manager to join our team at Pharmaron. As a Programme Manager, you will be responsible for managing packages of Metabolism studies and analytical project managing clinical metabolite profiling and identification studies.

Key Responsibilities
  • 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 fulfill 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.
  • Plan work to ensure revenue recognition milestones on assigned studies are hit in the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilized.
  • Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports.
  • Address findings arising from QA audits and process inspections.
Programme Management
  • Under the guidance of the Team Leader, 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.
  • Under the guidance of the Team Leader, 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 organizations, 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.
  • Work closely with Operations for the scheduling of programmes and making sure they stay on track.
  • Maintain an overview of the 'big picture' of assigned programmes of work to ensure client's overall objectives are being met, while also keeping sight of the detail of the individual projects.
  • Prepare and update Gantt Charts for assigned programmes.
  • Monitor and manage individual project timelines, liaising with clients and with Operations/QA, as required.
  • Under the guidance of the Team Leader, discuss any significant changes to agreed timelines with Operations and if necessary escalate to the Director of Metabolism (particularly if they impact dosing or have financial implications).
  • 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 organizations.
  • Compile regular programme status reports and send to clients.
  • Actively participate in client facility visits where required.
  • Where appropriate, advise clients of further available services which could help progress their programme.
  • To study direct other regulated and non-regulated studies as required.
  • Contribute to the review and QC checking of all relevant study data packages and reports prior to submission to Quality Assurance as required.
Requirements
  • Project Management
  • Scientific data interpretation, reporting, and presentation skills
  • Effective written and verbal communication skills, including the ability to effectively present scientific findings to colleagues and clients
  • Proficiency in analytical techniques (HPLC/TLC/LC-MS)
  • Understanding of the drug/agrochemical development process