Senior Global Clinical Trial Transparency Manager
An internationally renowned pharmaceutical company is seeking to recruit a Senior Global Clinical Trial Transparency Manager to their office in the UK. The organisation works across a range of therapeutic sectors, including oncology, neurology, and gastroenterology. This position is an exciting opportunity to work with a global establishment that discovers and develops innovative therapies to help address unmet medical needs.
- Identifying, tracking, and managing risks for GCTT by applying comprehensive knowledge of disclosure and transparency.
- Liaising with GCTT team members, senior management, and regional Compliance and Risk Management to record risks, potential mitigation, implementation strategies
- Tracking and reporting overall compliance for GCTT with the company's Policy for Clinical Trial Data Access and the Disclosure of Clinical Trial Information, along with applicable regulations.
- Identifying and escalating risks and issues and proposing mitigation and remediation, as required, to GCTT management.
- Planning and managing the implementation and upgrading of specific systems projects, as delegated by the Head of GCTT and VP Central Services, to support GCTT activities from initiation to deployment and implementation of improvement projects/upgrade.
- Partnering with Senior Management from departments involved in transparency operations.
- Partnering and leading interactions with Senior Management of departments by managing studies, ensuring they and their departments are fully aware of their roles and responsibilities around transparency operations obligations.
- Ensuring GCTT team members provide appropriate support so their responsibilities may be met with minimal disruption to their other work.
- Working closely with the transparency operations vendor(s) to ensure that the contracts are executed in accordance with the company's specific requirements.
- 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 that required documentation to show adherence to relevant SOPs is archived appropriately.
- Contributing to the interpretation and assessment of the impact of emerging GCTT related regulations and applicable laws to maintain compliance for their impact on daily operations and generally assessing the GCTT operations processes to identify opportunities for improvements.
- Interpreting operational trends, anticipating their potential impact, providing input and proposing changes, and driving the change management effort to a business as usual state.
- Drafting and implementing appropriate process changes in agreement with line management.
- Preparing training materials and 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 and its changing requirements within the company globally.
- Managing other clinical transparency activities within GCTT as required.
Skills and Requirements:
- Education to B.Sc. level or equivalent.
- Experience working within the clinical trial transparency and data sharing area.
- Working knowledge of industry tools and solutions for preparation and sharing of data with third parties.
- Experience with implementation of industry tools and solutions.
- Working knowledge of preparing redacted clinical reports.
- Project management experience or similar leadership type role.
- Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, and PhRMA/EFPIA principles for responsible data sharing, etc.
- Knowledge of study registration and results disclosure on clinicaltrials.gov.
- Track record of driving and successfully completing time-sensitive projects across multiple departments.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 846 0646 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.