Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating unique clinical, medical affairs, and commercial insights into actionable outcomes, Syneos Health addresses modern market challenges effectively.
Our Clinical Development model places the customer and patient at the center of everything we do. With a focus on simplifying processes and enhancing efficiency, we strive to make Syneos Health not just easier to work with but also a great place to work.
Join a team of 29,000+ professionals across 110 countries who are passionate about changing lives through innovative therapies. At Syneos Health, Work Here Matters Everywhere.
Why Join Syneos Health?
- Career Growth: Opportunities for progression, technical training, and therapeutic area expertise.
- Total Self Culture: A supportive environment where you can authentically be yourself.
- Diversity & Inclusion: A commitment to fostering diverse perspectives for better innovation.
Job Description: Clinical Data Associate I (Inform EDC)
Key Responsibilities:
- Maintain awareness of project contracts and scope of work.
- Ensure compliance with study-specific Clinical Data Management Plans (DMP).
- Enter and review lab normal ranges in the Clinical Database Management System (CDMS).
- Perform discrepancy checks, validate data listings, and apply corrections per Data Validation Specifications (DVS).
- Manage Data Clarification Forms (DCFs) for paper-based studies, ensuring accurate CRF updates.
- Conduct internal QC checks via database listings against CRFs and DCFs.
- Assist in tracking project progress and generating status reports.
- Support database finalization and transfer to sponsors.
- Participate in internal/external audits and maintain Data Management Study Files (DMSF).
- Assist in study archival and electronic storage media creation per SOPs.
- Stay updated on DM systems, coding processes, and medical terminology.
Preferred Qualifications:
- BA/BS in Biological Sciences, Healthcare, or related fields.
- Experience with Clinical Data Management (CDM) practices and relational databases.
- Inform EDC systems experience is a strong advantage.
- Knowledge of ICH/GCP guidelines and medical terminology.
- Proficiency in MS Office (Word, Excel, email applications).
- Strong organizational, communication, and multitasking skills.
- Ability to work independently and in a team-oriented environment.
