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At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Motivated by our dedication to patients, we bring creative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.co.uk for more information.
You will join our Pharmaceutical business in the role of a trial management assistant and will be given a high level of exposure to many aspects of the Clinical Trials division. This is an office-based role. This is an exciting and unique opportunity to be at the forefront of drug development in one of Europe’s fastest growing top ten pharmaceutical businesses.
The focus of this position is to support operational aspects of Global Clinical Development Operations (GCDO) managed clinical trials. Scope of work will include tasks associated with trial start-up, execution or close out, in all phases of clinical trial development. The range of tasks will include activities assigned by the GCDO Program Leader, GCDO Trial Leader, Clinical Trial Manager, and/or GCDO Clinical Trial Administrators. It may vary to some degree depending on the therapeutic area and trial-specific requirements.
You will be expected to become familiar with the principle of International Committee of Harmonisation Good Clinical Practice (ICH GCP).
Main duties and responsibilities:
Duties may include, and may not be limited to
- Assist with activities which support trial management across the various phases of a trial (start-up, execution and close-out)
- Work on process improvement cross trial project, if required
- Attend and provide updates as required at cross functional study meetings
- Set up and / or manage trial-specific electronic systems (e.g. Clinical Trial Management System, data reporting tools etc) with expectations that study / data status information is available at all times
- Work with local Affiliates across multiple countries to ensure trial specific data are up-to-date, complete, accurate and consistent
- Develop and /or support clinical trial specific tracking
- Manage central Trial Master File across various phases of a trial
- Support management of global vendors involved in global and site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners
- Work cross-functionally with internal teams and external vendors
- Support all occurrences of internal and external audits and inspections
- Support the onboarding activities of placement student successors where possible
- Collaborate with the student cohort on fundraising and charity events
Requirements of the role:
- 2 years of degree level study completed
- Bioscience degree types only
Key skills and competencies:
- High level of accuracy and attention to detail
- Passion for working in the pharmaceutical industry
- Excellent communication skills both written and oral
- Seeks opportunities to learn and grow professionally
- Able to prioritise and manage own workload autonomously
- Flexible and adaptable team player
- Good at problem solving
- Actively seeks feedback, appreciates and uses constructive criticism
- Bounces back quickly from mistakes; learns and moves on quickly
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
Clinical Trial Coordination