IIT Study Manager - 12 month fixed term contract - United Kingdom
Want to know company name or location? Company managed [?]
- 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.
- 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
- 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