Global Clinical Trial Transparency Manager (Data Sharing)
Brandon Whates at CK Clinical is recruiting for a Senior Manager, Global Clinical Trial Transparency (Data Sharing), to join a global pharmaceutical company at their site based in Hertfordshire on a permanent basis.
The main purpose of the role will be to serve as a subject matter expert and primary point of contact for all transparency operations including clinical trial transparency risk and compliance management, data sharing and CSR redaction. They are looking for someone to provide leadership to the GCCT team, supporting them with transparency operations and performing clinical trial registration and results posting on data sharing websites including EudraCT and clinicaltrials.gov.
This is a relatively new role within the industry and our client will consider candidates from a broad range of backgrounds including medical writing, clinical operations and data management. Applicants will be considered as long as they can demonstrate experience working within clinical trial disclosures, or prior experience within clinical development and a willingness to learn new skills.
- Performing/coordinating all transparency operations activities in compliance with policy and procedures, and applicable regulations
- Working closely with the internal team and vendor to ensure they understand their roles and responsibilities related to transparency operations obligations
- Works with the internal team to ensure the source information is provided for disclosure activities in a timely manner
- Working closely with the transparency operations vendor(s) to ensure that the contracts are executed in accordance with specific requirements and work is completed in compliance with policy, procedures, and applicable regulations.
- Representing the company within industry working groups associated with transparency operations, as required.
- Ensuring transparency operations for upcoming and completed work is maintained and up-to-date and required documentation to show adherence to relevant SOPs is archived appropriately
- Process and Training: maintain process documents and training materials in line with regulation updates and acquired knowledge as required.
- Raising awareness of GCTT transparency operations and its changing requirements within the company globally as required.
- Supporting other clinical transparency activities within GCTT as required
- Education to B.Sc. level or equivalent
- Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
Demonstrated experience in the pharmaceutical industry, ideally with exposure to one of the following areas;
- Clinical trial transparency
- Clinical trial disclosure
- Medical writing
- Understanding of clinical development within the pharmaceutical industry.
- Experience with transparency operations
- Experience of supporting and managing tasks / projects, by establishing strong relationships and coordinating those resources (internal and external) to achieve deliverables in compliance with process and / or contract.
- Experience of working with different software packages and platforms.· Track record of driving and successfully completing time-sensitive projects across multiple departments
For more information or to apply for this position, please contact Brandon Whates on 01438 768715 or via email on firstname.lastname@example.org 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 46344 in all correspondence.