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

Celgene (company)


Posted on : 21 March 2017

Project Description

Description
  • Our company 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.


Summary
  • Manage the set up and initiation of company 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 Responsibilities
  • Set 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 company 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 company  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 company  staff as required to assess IIT status and provide support.
  • Interact with EU Medical Department and Medical Affairs personnel to ensure standardization 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 studies
  • Build capacity of the function to deal with future trials
  • Organise Investigator/Researcher meetings as appropriate
  • Manage IITs of strategic importance to the UK affiliate via Collaborative Model process



Qualifications
  • Life Science degree (prerequisite)


Skills and Knowledge Requirements
  • Relevant experience, preferably within the pharmaceutical industry (prerequisite)
  • Experience in clinical research and/or Project Management (prerequisite)
  • Strong Scientific Background
  • Strong identification with company s Values
  • Excellent Project Management skills
  • Previous Clinical Research/Investigator Initiated Trials experience
  • Strong IT skills
  • Excellent organizational skills and strong interpersonal skills
  • Excellent time management skills
  • Knowledge of Haematology, Oncology or Inflammation & Immunology an advantage but not a prerequisite

Locations

Hillingdon England UK

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