Global Clinical Trial Transparency - Hertfordshire
Hendre Moolman at CK Group is recruiting for a Global Clinical Trial Transparency contractor to join a company in the pharmaceutical industry at their site based in Hertfordshire on a 12 month.
Our client is a global Pharmaceutical company who place patients and their families at the forefront of everything they do.
The role is based at our client's site in Hertfordshire which is commutable from many towns from Middlesex to Cambridgeshire. There are good road and public transport networks and London is easily reachable. Hertfordshire boasts many landmarks as well as beautiful countryside.
The main purpose of the role will be to
- Perform all aspects of clinical trials registration and results posting
- Ensure compliance with the processes which support Clinical Trial Data Access and the Disclosure of Clinical Trial Information and applicable regulations
- Work closely with the internal teams and vendors to ensure they understand their roles and responsibilities related to disclosure obligations
Further responsibilities will include:
- Working closely with the vendor to ensure that the studies get registered and results get posted to major registries in compliance with policy, procedures, and applicable regulations.
- Maintaining process documents and training materials in line with regulation updates and acquired knowledge
- Ensuring awareness of existing and emerging guidance on public disclosure processes, requirements and information, including EMA, FDA and international regulatory requirements for transparency, registration, results posting content and format.
To succeed in this role, you will come from a background in Life Science degree, with good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing
Demonstrated experience in the pharmaceutical industry, with exposure to least one of the following areas; Clinical trial transparency, Clinical trial disclosure, or Medical writing
Understanding of clinical development within the pharmaceutical industry
For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46023 in all correspondence.