Clinical Data Manager

Kelly FSP is recruiting Clinical Data Managers at different levels (Junior and Senior) to join our team and support one of the worlds top five pharmaceutical companies. The Clinical Data Manager is responsible for delivering quality data management activities for clinical trials from study setup to closeout 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 SetUp:

• eCRF setup 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 thirdparty 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 13 years of Clinical Data Management experience preferably in Phase 1 and Phase 2 studies
• For Manager role 58 years of Clinical Data Management experience
• For Senior Manager role 815 years of Clinical Data Management experience
• Knowledge of Clinical Trial Development Processes and ICHGCP
• 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)

Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

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Remote Work :

No