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IIT Study Manager - 12 month fixed term contract United Kingdom,  

Posted on : 21 March 2017

Project Description

Req #: 17000461 Location: Hillingdon, England UK Job Category: Medical Work Location: Stockley Park, UK 1 Longwalk Road Stockley Park Hillingdon UB11 1DB Organization: Celgene UK Marketing LTD Schedule: Full-time Shift: Day Job Employee Status: Limited Term Job Type: Standard Job Level: Individual Contributor Travel: Yes, 10 % of the Time DescriptionCelgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.SummaryManage the set up and initiation of Celgene UK and Ireland Investigator Initiated Trials in Haematology, Oncology and Inflammation & Immunology from proposal to study closure. Provide reports and activity summaries to the overall business unit to maintain awareness of the status of the IIT programme.Ad-hoc travel, primarily in the UK and ocasionally internationally may be required for this role.Role and ResponsibilitiesSet up Haematology, Oncology and Inflammation & Immunology (I&I) IITs from first receipt of proposal to study closure.Manage the process and track drug orders for Romidepsin Named Patient Program, where appropriate.Maintain a database to log and track IIT status.Provide monthly status reports, dash boards and other activity summaries to manager, MD and the wider Business Unit where required in order to enhance awareness of the IIT programme. Provide point contact for all IIT related queries including drug supply, contract status, protocol amendments and safety updates. Appropriate storage of electronic and hard copy essential documentation.Create SOPs/WPs for local IIT management.Communication with/visits to sites to assist with proposals, review IIT status or drug accountability.Assist Regional Medical Liaisons (RMLs) with new IIT proposals for support, ensure proposals are in line with Celgene Global Research Strategy and, where appropriate, champion the proposal at review meetings. Assist in contract negotiations with investigators and Sponsors as required, providing point contact for European contract and legal teams.Work with Celgene IMSC department to process and track drug orders for IITs. Ensure all key stages and activities for studies are established and achieved.Provide IMSC department with drug forecasts for all IITs and ensure all documentation is available for QP release.  Liaise with RML team or other Celgene staff as required to assess IIT status and provide support.Interact with EU Medical Department and Medical Affairs personnel to ensure standardisation and implementation of best standards and practices.Manage and respond to queries related to drug supply, logistics and regulatory approval.Manage the internal review and tracking of all study documentation, including amendments, publications, reports and safety reports.Provide RMLs with latest safety updates and procedural changes related to IIT management and ensure these are implemented.Ensure consistent implementation of best practice.Ensure accurate and accessible storage of study documents.Maintenance of electronic and existing paper folders as repositories for all relevant IIT study documentation (inc IBs, CDAs, Contracts, CTAs, Ethics).Develop capacity for expansion of IIT studiesBuild capacity of the function to deal with future trialsOrganise Investigator/Researcher meetings as appropriateManage IITs of strategic importance to the UK affiliate via Collaborative Model processQualificationsLife Science degree (prerequisite)Skills and Knowledge RequirementsRelevant experience, preferably within the pharmaceutical industry (prerequisite)Experience in clinical research and/or Project Management (prerequisite)Strong Scientific BackgroundStrong identification with Celgene s ValuesExcellent Project Management skillsPrevious Clinical Research/Investigator Initiated Trials experienceStrong IT skillsExcellent organizational skills and strong interpersonal skillsExcellent time management skillsKnowledge of Haematology, Oncology or Inflammation & Immunology an advantage but not a prerequisite


Hillingdon England UK

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