Senior Registry and Results Disclosure Lead
2 weeks ago
CK Group are recruiting for a Senior Disclosure Lead to join a pharmaceutical company with a site based in Slough on a contract basis for 12 months. This role is inside IR35.
**The Role**:
The main purpose of the role will be to
- Work on scientific data handling, cross-functional project management and communication to deliver timely and compliant disclosure of Company-sponsored clinical trial data.
- Execute disclosure activities for sponsored trials, including protocol registration and results disclosure.
- Ensure compliance with legal requirements and in line with Company transparency commitments, and provide high-quality disclosure deliverables.
- Post trial information onto ClinicialTnals.gov, EudraCT and specific local registries.
**Further responsibilities will include**:
- Managing trial protocol registrations and coordinating results reporting on ClinicalTnals.gov & EudraCT within mandated timeframes
- Coordinating review and approval of study Disclosure Plan & Results Master Document by relevant stakeholders
- Updating project tracking systems, maintaining complete, accurate & consistent records reflecting entry of data onto registries, and archiving related documentation
**Your Background**:
To succeed in this role, you will come from a background relevant experience with clinical development, preferably trial &/or data management &/or biostatistics, or Regulatory Affairs (which could also have been acquired through academia)
- Comfortable with using data/document management systems (CTMS, XML)
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54772 in all correspondence.
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