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EDC Analyst
MakroCare
posted 5mon ago
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Flexible timing
Key skills for the job
Job Description
The EDC Analyst plays a critical role in managing clinical trial data by overseeing Electronic Data Capture (EDC) systems and providing analytical support. Ideal candidates will have a background as a Clinical Research Associate and experience in supporting EDC and Clinical Trial Data Applications/Software tools.
This role requires collaboration with cross-functional teams to maintain EDC platforms, optimize data collection processes, and contribute to the overall success of clinical trials.
Key Responsibilities:
- Manage and support the design and development of EDC databases.
- Lead the analysis, development, and enhancement of functional and technical processes to improve workflow.
- Collaborate with stakeholders using an Agile approach to enhance system functionality and efficiency.
- Ensure the accuracy and completeness of clinical trial data within EDC systems.
- Develop and maintain data validation specifications and edit check programs.
- Collaborate with clinical and data management teams to resolve data discrepancies.
- Conduct user acceptance testing (UAT) for EDC system enhancements.
- Contribute to process improvement initiatives for data collection and management.
- Ensure compliance with regulatory guidelines and industry standards.
- Participate in audits and inspections related to EDC systems and data management.
- Stay updated on technological advancements in EDC and data management.
- Ensure all documentation complies with SOPs and supports UAT and other operational needs.
- Coordinate RFPs with stakeholders for vendor and application selection, ensuring quality standards are met.
Required Qualifications:
- bachelors degree in Life Sciences or a related field.
- Minimum of 2 years of experience in clinical data management or a related role.
- Proficiency in EDC systems (eg, Medidata Rave, Oracle InForm).
- Knowledge of regulatory requirements for clinical trials.
- Excellent problem-solving and analytical skills.
- Ability to work effectively in a team environment.
- Strong communication and interpersonal skills.
- Detail-oriented approach with a commitment to data quality.
- Familiarity with best practices in electronic data capture.
- Experience in user acceptance testing (UAT) for EDC systems.
- Understanding of data integration and migration processes.
- Certification in clinical data management is a plus.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
MakroCare Benefits
Submitted by Company
Team Outings Education Assistance Soft Skill Training Health Insurance International Relocation
Submitted by Employees
Work From Home 
Soft Skill Training 
Health Insurance 
Job Training 
Team Outings 
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