Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
Post : Senior Clinical Data Coordinator
Job Description
• Ensure data quality by conducting data management activities including data validation, data review, etc. following study timelines. Maintain clear reporting on DM activities in alignment with study teams and management needs.
• Monitor the progress of data cleaning activities and generate status reports for the Study Data Manager and study team.
• Participate in the writing of study plans including Data Management Plan, Centralized Monitoring Plan etc. as per timelines defined with the study team.
• Participate in the writing of UAT Plans and perform testing for database, listings, patient profile and safety notification tool, providing feedback to programming team and Study Data Manager to collaboratively solve issues found both during initial database set up and database revision.
• Conduct centralized monitoring activities according to Centralized Monitoring Plan. Ensure clear, concise, consistent communication on data management activities at study level (including risks identification, monitoring, alert and escalation)
• Acts as mentor for new CDC. Identifies opportunities to streamline processes and increase data quality.
• Provides input to new approaches and initiatives within data management activities, with a high level of team spirit and motivation. Support and act as back-up of the Study Data Manager, when requested.
Candidate Profile
• Experience : Experience in Clinical Data Management.
• Soft skills : Excellent accuracy and attentiveness to detail
• Excellent written and oral communication
• Good team player and ability to foster a good collaboration within CDM and with clinical study team
• Technical skills : Strong experience with CDM and Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.
• Knowledge of database technologies and ability to acquire and apply new technical skills.
• Proficiency in Microsoft Office Suite (intermediate level)
• Education : Bachelor’s degree or above, preferably in a life science or drug development related field.
• Languages: Good English skills (both verbal and written).
Additional Information
Qualification : Bachelor’s degree or above, preferably in a life science
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job Type : Permanent
End Date : 30th May 2025
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