Syneos Health is hiring a Clinical Data Associate I/II/III to assist in all clinical data management activities for complex clinical trials. You will demonstrate high proficiency in core responsibilities and provide guidance to other Clinical Data Associates. At Syneos Health, we foster a Total Self culture where you can authentically be yourself, dedicated to taking care of our people and bringing together diversity of thoughts, backgrounds, cultures, and perspectives.

What You'll Do

Maintain awareness of contract and scope of work for assigned projects.
Review and adhere to study-specific Clinical Data Management Plans.
Create and enter test data for User Acceptance Testing (UAT) and perform UAT for data entry screens, edits, listings, roles, and Targeted Source Data Verification (SDV) configuration.
Receive and enter lab normal ranges and complete CDMS-specific access forms.
Perform reviews of discrepancy output and validation listings, issuing queries or applying corrections, and resolve answered queries.
For paper studies, review answered Data Clarification Forms (DCFs), edit the CRF database, perform internal QC checks, and ensure all CRFs and DCFs are filed per guidelines.
For EDC studies, perform DM quality review, internal QC checks, and create electronic storage media per SOPs.
Participate in internal meetings and audits, and file documentation in the Data Management Study File (DMSF).
Maintain proficiency in Data Management systems through regular training.
Perform SAS mapping QC and coordinate the work of other CDAs assigned to the project.
Provide training on data management activities and systems.
Ensure data from external databases (lab, e-diary, PK, IRT) are consistent with the clinical database.
Complete tasks within timeframe, prioritize multiple tasks, and proactively communicate availability.
Run data cleaning and status reports, perform Serious Adverse Event (SAE) reconciliations, and perform peer review for other CDAs.
Understand how data management interacts with other Data Operations teams.
Perform QC of Data Dictionary for code lists and create ad-hoc data cleaning reports and specifications.
Perform post-migration testing on screens, edit checks, matrices, and role changes.
Participate in customer and third party meetings, distributing information and minutes.
Review database design specifications and design/review CRF/eCRF including visit structure.
Provide input into the Data Validation Specification (DVS) including creation of edit checks.
Act as Project Data Manager (PDM) back up for specific activities.
Create Discoverer, BOXI, J-Review Reports and update the Data Management Plan under PDM guidance.
Support PDM on updating documents according to Trusted Process and create/update the CRF/eCRF Completion Guidelines.
May fill-in the Data Transfer Request Form for delivering data and understand the coding process and purpose of interim, dry run, and data cut.

What We're Looking For

BA/BS degree in biological sciences, natural science, or related healthcare field.
Minimum 2 to 5 years of experience with Clinical Data Management practices and relational database management software systems.
Strong background in conducting CDM activities.
Must have experience in Conduct & Closeout, preferably in Inform EDC.
Experience in Conduct: Discrepancy Management, Vendor Recon, SAE, PK & PD, IVRS and lab, Data Cleaning, Manual data review.
Strong communication, presentation, and interpersonal skills, both written and spoken.
Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications.
Excellent speed and accuracy of keyboard skills and familiarity with medical terminology.
Good organizational, planning, and time management skills with ability to multitask under tight deadlines.
Ability to be flexible, adapt to change, and work independently as well as part of a team.
Responsible for performing activities in compliance with applicable Corporate Business Practices, SOPs, and Working Instructions.
Minimal travel may be required (up to 25%).

Nice to Have

Work experience in clinical research, drug development, data management, or other healthcare environment.
Startup experience is preferred.
Therapeutic area experience in Vaccine & Oncology.
Experience in CPT/Metrics.