location_onLondon, UK
watch_later Posted: Aug 28, 2024
Skills Required
Nice To Have skills
Job Description
Kelly FSP is recruiting Clinical Data Managers at different levels (Junior and Senior) to join our team and support one of the world's top five pharmaceutical companies. The Clinical Data Manager is responsible for delivering quality data management activities for clinical trials from study set-up to close-out, ensuring compliance with GCP and applicable regulatory guidance.
Main Activities:
Leadership: Provide Data Management (DM) leadership and expertise as a core member of the Clinical Trial Team.
Study Set-Up:
- eCRF set-up and UATs
- Development/review of study plans and documents
- Organize and conduct strategy meetings with the study team
- Interaction with external vendors
Study Conduct/Closure:
- Manage data validation and queries
- Review data reports and implement corrective actions
- Handle third-party data loading and reconciliation
- Organize and conduct data review and database lock meetings
- eTMF archiving
- Vendor Management: Maintain a good working relationship with external vendors and monitor their performance. Implement mitigation actions as necessary.
Qualifications:
- Bachelor/Master/PhD degree in life sciences, mathematics, or related area
- For Junior role - 1-3 years of Clinical Data Management experience, preferably in Phase 1 and Phase 2 studies
- For Manager role - 5-8 years of Clinical Data Management experience
- For Senior Manager role - 8-15 years of Clinical Data Management experience
- Knowledge of Clinical Trial Development Processes and ICH-GCP
- Strong communication and interpersonal skills
- Experience with clinical study management tools and
- systemsAbility to manage multiple external data systems
- Proficiency in Microsoft Office
- Fluent in English (written and spoken)