This job posting for a Clinical Data Associate II (Medidata Rave) at Syneos Health in Mumbai and Pune offers an excellent opportunity for professionals with 2 to 4.5 years of experience in clinical data management. Here’s a summary of the key points:
Job Responsibilities:
- Handle all clinical data management activities for clinical trials, including User Acceptance Testing (UAT), lab data entry, discrepancy reviews, and data validation.
- Perform data entry and quality checks for both paper and Electronic Data Capture (EDC) studies.
- Coordinate tasks like Serious Adverse Event (SAE) reconciliations, interim data reviews, and database management.
- Work within the scope of contracts and study-specific Clinical Data Management Plans.
- Provide guidance to other Clinical Data Associates and possibly coordinate their work.
Qualifications:
- Education: BA/BS degree in biological sciences or related fields.
- Experience: 2 to 4.5 years in clinical data management, with at least 1 year of experience with Medidata Rave.
- Skills: Experience with Query Management, Spotfire, SAE reconciliation, lab query management, and startup tasks like UAT and DM documentation. Hands-on exposure to Oncology trials preferred, along with knowledge in Cardiovascular, Neurology, Respiratory, Infectious Disease, and Gastroenterology therapeutic areas.
- Technical Proficiency: Familiarity with ICH/Good Clinical Practices, medical terminology, MS Office, and relational database management systems.
- Other Requirements: Strong communication, organizational, and multitasking skills. Ability to work both independently and as part of a team. Minimal travel may be required (up to 25%).
Why Syneos Health:
- Syneos Health emphasizes career development, peer recognition, and a supportive work environment.
- The company values diversity and inclusion, and encourages applications from individuals with transferable skills.
