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.