Clinion is a leading provider of clinical trial management software and data solutions. Known for its robust and user-friendly EDC systems, Clinion empowers healthcare organizations to conduct seamless and compliant clinical trials. Our commitment to innovation and excellence makes us a trusted name in the industry.
Key Responsibilities
As a Support BA in Clinical Data Management, your primary focus will be on:
- CRF Design and Configuration
- Designing Case Report Forms (CRFs) in the EDC system.
- Configuring study-specific logic, edit checks, and workflows to maintain data integrity.
- System Setup and Testing
- Setting up the EDC environment, including user roles, permissions, and configurations.
- Conducting unit testing, user acceptance testing (UAT), and validation to meet regulatory requirements.
- Collaboration and Training
- Working with clinical data managers, statisticians, and other stakeholders to align on study objectives.
- Providing training to study teams and site staff on EDC usage.
- Compliance and Documentation
- Ensuring adherence to FDA 21 CFR Part 11, ICH GCP, and other regulatory guidelines.
- Documenting EDC design, testing scripts, and validation reports meticulously.
- Technical Support and Security
- Acting as a primary contact for EDC-related technical queries.
- Monitoring system performance and safeguarding clinical trial data with advanced security measures.
Qualifications and Eligibility
To qualify for this role, you must meet the following criteria:
- Education: A degree in Biotechnology, Pharmacy, or Microbiology.
- Experience: Freshers or candidates with up to 2 years of experience.
- Strong knowledge of clinical trial processes and regulatory standards is an advantage.
Key Skills
- Proficiency in designing and managing EDC systems.
- Knowledge of GCP and FDA 21 CFR Part 11 compliance.
- Excellent analytical and problem-solving skills.
- Effective communication and ability to train others.
- Strong attention to detail and organizational skills.
How to Apply
Ready to be a part of Clinion’s innovative team? Send your CV and portfolio to saikiran.p@quadone.com. Mention the subject line “Application for Support BA (Clinical Data Management)” for better visibility.
