Overview

Reference Number: JO-2109-475668
Study Manager
Rate: Negotiable
Job Type: Contract
Location: Cambridge

Job Title: Study Manager
Pay Rate: 500 a day LTD
12 Month contract
Remote UK Occasional travel Cambridge

Position Summary

  • Plan and manage Investigational Medicinal Product (IMP) supply for assigned clinical studies
  • Work collaboratively within Logistics and Clinical Supply (LCS) to ensure seamless delivery by LCS Matrix team (Study, Vendor, Distribution and Systems management activities)
  • Liaise with interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution, including on-going responsiveness to any changes that may impact supply strategy.
  • Contribute to the operational effectiveness of LCS

Major Duties and Responsibilities

  • Plan and manage IMP supply for assigned clinical studies. The Associate Study Manager will typically be responsible for management of a number of clinical studies which may include a portfolio of External Sponsored Research studies (ESR) and may involve a few different development compounds. Studies may be domestic and /or international in scope and may be in clinical development Phase 1 or 2
    • Using defined tools and procedures create documentation required to support IMP supply activities
    • Provide LCS input into all relevant study related documents
    • Maintain IMP study documentation in defined document repositories, as appropriate for GXP purposes e.g. Trial Master File (TMF). Ensure all documentation is appropriately filed and is current, accurate, complete and delivered according to agreed timelines.
    • Ensure necessary IMP related documentation is available to the Product Specification File.
    • Maintain oversight of the activities related to processing of IMP product complaints, non-conformances, product recalls or inquiries pertaining to assigned clinical studies
  • As required, provide support to enable planning and management of more complex (e.g. later stage) clinical studies working together with Technical Manager or other assigned Study Manager or Senior Manager within LCS
  • Assist in the review and preparation of departmental SOPs, systems and processes to support maintenance, improvement and future growth of Study Management best practice
  • Plan and lead regular LCS Matrix meetings for assigned studies. Agree scope of work, and more detailed plans and timelines with Systems, Distribution, and Vendor Management representatives and collaborate to achieve agreed supply activities
  • Create, develop and maintain LCS clinical supply strategy for IMP
  • Collaborate in ensuring responsiveness to changes in supply remit and ensure LCS review and timely resolution of issues and challenges as they arise,
  • As a member of the Supply Continuity Team (SCT) contribute to and influence the development /supply strategy for assigned studies, ensuring that risks / opportunities for supply optimization are discussed
  • Create, maintain and communicate within Smart Supplies Forecasting a dynamic project demand forecast for assigned clinical studies
  • Represent LCS as an engaged and active participant at the Clinical Trial Team (CTT). Ensure good information exchange in relation to current supply activities, influence for effective and timely consideration of any change scenarios that may impact supply plans, and ensure dynamic interface with the SCT to align planning and implementation of any agreed changes
  • Build relationships with cross-functional groups to support and enable activities associated with IMP release. This includes activities such as kit activation and confirmation of release in the appropriate LCS systems
  • Liaise closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines
  • Partner with stakeholder departments to identify critical challenges and risks associated with IMP supply to the clinic. Communicate and provide input into risk management plans
  • Attend and actively participate in LCS departmental meetings
  • Participate where required in LCS departmental and/or assigned cross-functional process improvement initiatives
  • Apply own training and expertise to effectively deliver against flexible assignments within other aligned LCS roles as required
  • Mentor other members of staff (members of LCS, MEDImatch etc.) assigned to flexible roles within the Study Management team, and provide back-up support to other staff members as required
  • Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required

Special Skills/Abilities
This position requires a highly organized individual who demonstrates personal flexibility, initiative and an ability to work with minimal direct supervision on a day to day basis. The Associate Study Manager must possess excellent attention to detail, while also demonstrating skills for organizing, planning, coordination, teamwork, and communication (oral, written and interpersonal). Proficiency in Microsoft Outlook, Word, Excel and Power Point is expected.

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