Senior Associate, Global Clinical Trial Transparency - Hertfordshire
Sam Whyley-Smith at CK Clinical is recruiting for a Senior Associate, Global Clinical Trial Transparency to join a Global Pharmaceutical Company based in Hertfordshire on a permanent basis.
Responsibilities will include but will not be limited to the following activities:
- Ensure information on the site i.e. study information required for listing and enquiry metrics, are maintained, perform/coordinate all disclosure activities related to enquiries and research proposals, and represent company on DSC Working Call / DSC Forum meetings.
- Disclosure Governance Committee: provide content and topics to the development of meeting agendas and materials as required.
- Clinical Study Document Redaction: Manage the process for the redaction of clinical study documents e.g. under EMA Policy 0043 / 0070. Prepare document packages for redaction by internal team members, support training of internal team members, coordinate and track the internal and external redaction process.
- Lay Summary Development: manage the process for development of Lay Summary of Results (acquire source/input materials, coordinate/facilitate/drive review meetings, liaise with vendor).
- Ensure information on the externally facing site i.e. commitment, glossary, study information are maintained and in compliance with Trial Data Access and Disclosure Policy. Support future enhancements to the site functionality.
- Process and Training: maintain process documents and training materials in line with regulation updates and acquired knowledge.
- Maintain awareness of existing and emerging guidance on public disclosure processes, requirements and information, including EMA, FDA and international regulatory requirements for transparency, registration, results posting content and format.
- Other GCTT duties as required.
- Education to B.Sc. level or equivalent
- Experience working within the clinical trial transparency and data sharing area would be advantageous
- Knowledge of industry tools and solutions for preparation and sharing of data with third parties
- Knowledge of preparing redacted clinical reports, lay summaries, sharing of data.
- Experience 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
- Strong verbal and written communication skills that enable effective global meeting facilitation, make difficult concepts easy to understand, and demonstrate ability to articulate difficult issues.
- Ability to learn and/or adapt to new IT systems and software packages.
- Team player able to form strong (internal and external) relationships, demonstrating an ability to influence/persuade others.
- Ability to handle multiple tasks and/or projects simultaneously.
- Ability to understand and apply international regulations and guidelines and requirements related to clinical trial transparency.
- Flexible and proactive.
- Eye for detail.
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 580040 or via email on firstname.lastname@example.org. Please quote reference 46031 in all correspondence. 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 46031 in all correspondence.