Global Clinical Trial Transparency Manager (Data Sharing)
Brandon Whates at CK Clinical is recruiting for a Senior Manager, Global Clinical Trial Transparency Operations, to join a global pharmaceutical company at their site based in Hertfordshire on a permanent basis.
This position will be providing support to the wider global clinical trial transparency operations team. Working closely within the team, you will offer line management and leadership, ensuring risks are managed and compliance standards are met. This role will support the registration of information surrounding clinical trials, and posting these results on data sharing websites including EudraCT and clinicaltrials.gov.
You will serve as the primary point of contact for all transparency operations including data sharing, CSR redaction and risk and compliance management issues. Collaborating with vendors, GCTT staff and related internal teams to ensure they follow specific company guidelines and regulations surrounding the disclosure of clinical trial information.
- Providing leadership and line managing GCTT staff.
- Ensuring the conduct of all clinical trial transparency activities are in accordance with company policies and wider regulatory guidelines.
- Identifying and managing risks to GCTT by utilising a strong knowledge of disclosure and transparency activities, and liaising with internal teams and Senior Management to flag these risks, and potentially implement strategies to mitigate the risks.
- Working closely with vendors and internal teams, providing guidance surrounding transparency operations and their related responsibilities.
- Ensuring source information is collected in a timely manner for disclosures activities.
- Creating and maintaining training materials are available, and in line with recent guidelines. Delivering training on end-to-end transparency operations process, important process changes, and other associated topics to all the stakeholders involved.
- Raising awareness of GCTT transparency operations and its changing requirements within the company globally as required.
- Suggesting and implementing improved processes/systems to positively impact GCTT operations.
- Leading interactions and collaborating closely with Senior Management within different functional groups, ensuring they are aware of their responsibilities around clinical trial transparency operations, and that GCTT staff are providing appropriate support.
- 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 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 46344 in all correspondence.