Syneos Healthยฎ 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:ย Opportunities for progression, technical training, and therapeutic area expertise.
- Total Self Culture:ย A supportive environment where you canย authentically be yourself.
- Diversity & Inclusion:ย 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-specificย Clinical Data Management Plans (DMP).
- Enter and reviewย lab normal rangesย in the Clinical Database Management System (CDMS).
- Performย discrepancy checks, validate data listings, and apply corrections perย Data Validation Specifications (DVS).
- Manageย Data Clarification Forms (DCFs)ย for paper-based studies, ensuring accurate CRF updates.
- Conductย internal QC checksย via database listings against CRFs and DCFs.
- Assist inย tracking project progressย and generating status reports.
- Supportย database finalization and transferย to sponsors.
- Participate inย internal/external auditsย and maintainย Data Management Study Files (DMSF).
- Assist inย study archivalย and electronic storage media creation per SOPs.
- Stay updated onย DM systems, coding processes, and medical terminology.
Preferred Qualifications:
- BA/BS in Biological Sciences, Healthcare, or related fields.
- Experience withย Clinical Data Management (CDM) practicesย andย relational databases.
- Inform EDC systems experienceย is a strong advantage.
- Knowledge ofย ICH/GCP guidelinesย andย medical terminology.
- Proficiency inย MS Office (Word, Excel, email applications).
- Strongย organizational, communication, and multitasking skills.
- Ability to work independently and in aย team-oriented environment.
