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 five synergistic businesses focused in three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our group of complementary 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. Through five businesses, Clinigen Clinical Trial Services, Idis Managed Access, Idis Global Access, Link Healthcare and Clinigen Specialty Pharmaceuticals, we provide patient access to our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials. We are currently 500+ people, headquartered in Burton-on-Trent in the UK, with offices in London, Weybridge, Surrey, the US, Australia, China, Japan, South Africa and Singapore. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while physicians and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.
The role is 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 MAP clients who require this type of support.
The Key responsibilities for this role are:
During the start up phase of a new MAP program work with the MAP Programme 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
During the course of the MAP program, as the dedicated Medical Data Specialist, interact with Idis MAP team, Client and Pharmacists/Physicians participating in the MAP on a regular basis to deliver:
- 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 Programme Operations team in the UK in relation to data collection from the sites.
- Preparation of any required status reports on the data from the program including reports required by regulatory agencies if Idis is responsible for this.
- Transfer of the Adverse Event findings which are described in the forms to the client’s Pharmacovigilance Department, or alternatively to the Idis Pharmacovigilance responsible person.
- Work with MAP Medical Affairs Team to ensure all enquiries are efficiently and accurately addressed
- Support the MI and Quality departments in the event of a recall or quality complaint.
- Adhere to regulatory, quality and compliance guidelines and appropriate level of SOP competence measured against Idis quality standards.
At the end of a MAP program ensure the following are completed:
- All data are collected from sites
- All agreed reports are drafted and reviewed as agreed with the client
The successful candidate will have the following:
- Relevant Science degree
- 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 send a recent copy of your CV to email@example.com and a member of the Resourcing team will be in touch.