Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.
We are currently 1200+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and the North East and global offices in the US, Australia, New Zealand, Japan, Hong Kong, South Africa, Singapore and Athens. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.
The Real World Data Specialist will be responsible for providing medical operations support (e.g. protocol design, writing SOPs, set up of data collection tool, remote or on site monitoring and preparing reports) for Managed Access clients who require this type of support
This position is a 1 year fixed term contract based at our Weybridge office
Responsibilities (Not exhaustive)
- During the start-up phase of a new Managed Access program (MAP) work with the Program
- Director and client to deliver the following:
- Any treatment guidance/protocols or other medical documents required for the program
- Set up of required data capture tool
- Monitoring plan if needed
- Delivery of treatment guidance/protocols, data capture tools to all the Physicians and Pharmacists who need it (note this may be done via MAP operations team, but the medical operations specialist needs to ensure this happens as appropriate and deal with any queries related to these items)
- Answers Pharmacists/Physicians questions related to treatment guidance or data capture and liaising with MAP team or Client(s) team as required. This may involve visiting sites with specific issues or even following an agreed monitoring plan
- Collection of all the data from patients in line with the agreed treatment guidance/protocol from the physicians/pharmacists and checking for completeness
- Engage with the site management coordinators in the US and the Program Operations team in the UK in relation to data collection from the sites
- Transfer of the Adverse Event findings which are described in the forms to the client’s Pharmacovigilance Department, or alternatively to the Pharmacovigilance responsible person
- Adhere to regulatory, quality and compliance guidelines and appropriate level of SOP competence measured against Clinigen’s quality standards
- Science based degree or equivalent
- Demonstrable experience in the clinical operations field ideally including site monitoring, data management and report writing
- Demonstrable experience of protocol and SOP design and development
- Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus
- Proven experience of working to meet high standards and provide excellent customer service
- Proven experience with clinical data management tools
If this role is of interest to you, please email a recent copy of your CV and a covering letter to email@example.com and a member of the Talent Acquisition team will be in touch.