Senior Clinical Data Coordinator

Job title: Senior Clinical Data Coordinator

• Location:IN / Hyderabad

About the job

The Senior Clinical Data Coordinator (CDC) is responsible for routine data management activities during the course of a study complying with GCP and applicable regulatory guidance to ensure the generation of accurate, complete and consistent clinical databases.

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Clinical Data Coordinator within our Clinical Data Management, you’ll support the Study Data Manager in conducting study data management activities, ensuring his/her activities are completed per agreed timelines. Candidate is responsible for the quality of its own deliverables.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Major Responsibilities:

• 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.

About you

• 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).

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Join an international innovative biopharma company. 

• Participate in the evolution of Clinical Data Management and deployment of innovations. 

“Sanofi is at the forefront of the Clinical Data Management Modernization. Our ambitions are significant but pragmatic. The speed of change unprecedented but achievable. Join us of you want to help us transform our vision into a reality!”