Clinical Study Specialist
Charlene Dutchman at CK Clinical is recruiting for a Principal/Senior Clinical Study Specialist to join a leading Global Pharmaceutical Company based in Buckinghamshire, on a full time, temporary basis, for 12 month initially.
As a Principal/Senior Clinical Study Specialist you will obtain, evaluate, and execute all essential clinical trial documents, related to site start-up, and align execution activities with agreed upon project priorities, timings and quality specifications.
Key Accountabilities/Responsibilities of a Principal/Senior Clinical Study Specialist will include the following:
- Responsibility for the logistical tasks associated with the preparation, collation and review of the regulatory documents submission package.
- Ensuring distribution of draft essential documents to the selected sites.
- Ensuring the accuracy and quality of site start-up deliverables by reviewing deliverables with reference to company standards.
- Maintaining the tracking of project metrics in RDCM tracker and providing status updates.
- Confirming the drug release documents are received in-house and follows-up with site if documents are missing or incomplete.
- Responsibility for on-going regulatory document maintenance.- Ensuring follow-up with site if documents are missing or incomplete.
- Ensuring the distribution of final documents as appropriate.
- Coordination of site documents via external vendor including preparation of the Site Binder / SIV package.- May have responsibility for the green light release of the study site and IxRS activation.
- Responsibility for the set-up, maintenance and metrics reporting from the CTMS / Start-up systems for clinical studies.
- Participating in testing, validation and implementation of new CTMS / Start-up system features and other clinical system interfaces. Provides centralized CTMS / Start-up system setup services.
Participating in all relevant and required SOP and in-house training seminars.As a Principal/Senior Clinical Study Specialist, you will have the following qualifications, skills and experience:
A Bachelor's degree, preferably in a science or health-related discipline.
- Previous experience of working in a clinical / regulatory documents / site start-up role is preferred.
- Proven experience working with in a pharmaceutical or CRO environment is preferred.
- Strong communication and decision making skills.
- Planning/Organization/Project Management Skills
For more information or to apply for this position please contact Charlene Dutchman on 01246 45 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical 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 CL33691 in all correspondence.