Profile:
Project Leader - Clinical Supplies
Globally manages the interfaces between Pre-clinical and Clinical Development teams and externally, with customers and suppliers, for several clinical programmes, ensuring supplies are delivered on time and to budget. Independently manages multiple projects and priorities worldwide
RESPONSIBILITIES:
· Address Clinical R&D, Country Medical Department, Regulatory and Pharmaceutical Development issues as they relate to clinical trial supplies by providing technical expertise to, participating in or leading Clinical Supply Delivery Teams; proactively apply problem-solving skills to scientific and technical issues to advance projects and ensure that CTS activities are not on the critical path
· Determine and implement the initial timeline, budget, medication and component requirements needed for preparation of the Clinical Supply Contracts (CSC) for phase I through to IV clinical protocols world-wide
· Develop the study schematic and confer with the appropriate departments to develop a packaging plan and ensure completion within agreed timelines
· Determine the supply packing and distribution strategy for local, regional and global studies, incorporating IVR (RAMOS) requirements, as applicable
· Create the Study Medication Section of the clinical protocol as required
· Communicate CTS policy, requirements and initiatives, address other departments' concerns regarding their impact and ensure compliance.
· Present protocol specific supply logistics and RAMOS processes to Physicians and Study Coordinators attending Clinical Monitor and Investigator meetings.
· Interact effectively with international groups on supply issues.
· Represent CTSP Projects Team on Departmental committees and initiatives, review and update existing SOPs and identify future procedural requirements.
· Ensure prompt resolution of complaints and quality incidents, identify and implement corrective and preventative actions; ensure compliance with all quality & safety requirements relating to CTSP business processes
Budget - responsible for delivering to budget, typically up to £3M per project
EXPERTISE:
· Degree in Pharmacy, Pharmaceutical Sciences or equivalent, or at equivalent experience working in an R&D environment and a good knowledge of the drug development and clinical study processes.
· Proven communication (oral and written), influence and negotiation skills
· Possesses a high degree of accuracy and attention to detail
· Has a working knowledge of GMPs/GCPs and country regulations relating to clinical trial supplies.
· Demonstrated technical knowledge in computer skills
· Proven team player, good interpersonal skills
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
| Consultant: |
Natasha Grace |
