Company Name:-
Cytel, India

Job Location:-
Pune, Maharashtra

Job Summary:-
Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful.

Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team.

You will support Phase I –IV clinical studies across a variety of therapeutic areas.

If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!
The Clinical Data Manager works with Data Management performing a variety of data related tasks.

General Data Management responsibilities:
Perform and support data activities, processes & metrics
Execute secure and effective data procedures in collaboration with data management team members
Understand and comply with core operating procedures and working instructions
Ensure the completeness and validity of data entered into the database
Maintain the integrity of data
Specific responsibilities:
Independently manage portions of a project
Identify risks to project deliverables and timelines and notifies the appropriate personnel
Manage EDC user access and troubleshoot issues
Create and run data management reports
Test database design
Document and address the testing outcome
Validate edit checks and system settings
With minimal or no supervision, will
Create data management documentation including mock CRF, completion guidelines, DMP and test specifications
Participate in the design of Electronic Data Capture (EDC) components
Participate in query discrepancy resolution and document the data trends
Perform manual listing review
Perform other data related tasks
With appropriate supervision, will perform:
SAE reconciliation
External data coordination and reconciliation
Edit check specification creation and modifications
Preparation and execution of change request forms
Critical and final data QC prior to database lock
Qualifications and Experience:
Bachelor’s

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