Senior Associate/Manager, Disclosure, Global Clinical Trial Transparency - 12 Month FTCCK Group are recruiting for a Senior Associate or Manager, 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.
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 to meet disclosure obligations for the registration.maintenance and results posting on clinicaltrials.gov, clinicaltrialsregistry.eu and any other applicable repositories and support team members assigned to disclosure operations, ensuring they follow process.Work closely with internal and external teams to fulfil and ensure that they understand transparency and disclosure obligations.Work closely with the vendor to ensure that disclosure obligations are performed 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.Support and contribute to, as an SME, the implementation and upgrade of the disclosure system, from initiation to deployment.Contributing to the regular assessment of disclosure activities for risk, and that any risks identified are tracked, managed, and potential mitigation and implementation strategies are developed.Preparing training materials and delivering training on end-to-end disclosure operations process, important process changes, and other associated topics to all the stakeholders involved.Contribute to raising awareness of clinical trial disclosure and its changing requirements within the company globally, as required.
Your Background: Manager, you will need: Educated to degree level or above in life sciences or a related field.Strong working knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.Proven and demonstrated experience with clinical trial transparency or disclosure within the pharmaceutical industry as an SME within the clinical trial disclosure area.Strong working knowledge of study registration and results disclosure on clinicaltrials.gov.Understanding of clinical development within the pharmaceutical industry.Excellent communication and relationship building skills with the ability to drive projects with conflicting priorities in a matrix team environment.