Job Description
Job Description
CK Group are recruiting for a Manager/Senior Associate, Global Clinical Trial Transparency and Disclosure with a well-established and successful global pharmaceutical Company based in Hatfield, Hertfordshire on a fixed term contract basis for 12 months.
Senior Associate Role:
To perform all aspects of clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide (disclosure operations process) as directed and ensure compliance with the processes which support the company policy for Clinical Trial Transparency and applicable regulations.
Manager Role:
To ensure compliance with the disclosure processes which support the company Policy for Clinical Trial Transparency and applicable regulations and demonstrate success supporting the activities of team members assigned to disclosure operations, working collaboratively and independently as required, with internal and external team members to ensure Global Clinical Trial Transparency disclosure responsibilities are achieved.
Key duties will include:
- Performing/coordinating all activities for the registration and results posting to clinicaltrials.gov, EudraCT, and similar databases worldwide.
- Work closely with internal and external teams to fulfil and ensure that they understand transparency and disclosure obligations.
- Work with the internal team to ensure the source information is provided for disclosure activities in a timely manner.
- Work closely with the vendor to ensure that the studies are registered and results are posted to major registries in compliance with policy, procedures, and applicable regulations.
- Maintain awareness of existing and emerging guidance on disclosure processes, updating internal processes and performing training where needed.
Your Background:
- Educated to degree level or above in life sciences or a related field.
- Good working knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
- Proven experience with clinical trial transparency or disclosure within the pharmaceutical industry and established as a subject matter expert in this field for the Manager level.
- Understanding of clinical development within the pharmaceutical industry.
- Excellent communication and relationship building skills with the ability to manage multiple tasks or projects simultaneously.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 103832 /103833 in all correspondence.