Job Title:
Senior Clinical Data Associate (External Data Associate)
Location:
IND – Remote
Job ID:
25101749
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We transform clinical, medical affairs, and commercial insights into actionable outcomes to address modern market realities.
Our Clinical Development model places the customer and patient at the center, continuously simplifying processes to make Syneos Health easier to work with. Whether in a Functional Service Provider or Full-Service environment, employees collaborate as passionate problem solvers to deliver life-changing therapies.
Employees: 29,000 across 110 countries
Mission Statement: Work here matters everywhere
Why Join Syneos Health:
Career development and progression opportunities
Supportive line management and training
Peer recognition and rewards programs
Inclusive Total Self culture fostering authenticity and belonging
Job Responsibilities:
Core Responsibilities:
Collaborate with Data Management (DM) and DM Quality Leads (DMQL) to manage vendor/data types using Veeva vendor tracker.
Create DTS and DTA based on vendor tracker using P21 standards.
Generate DS requests for missing standards.
Perform import review for test and production transfers, including milestone checks.
Implement protocol amendments and new requirements.
Conduct eCOA device UAT and create UAT test scripts.
Perform key mappings/unblinding rules.
Follow Good Documentation Practices (GDP) and ETMF review/approval processes.
Additional Responsibilities:
Maintain awareness of contract and scope of work; communicate status to Project Manager (PM) or Biometrics Project Manager (BPM).
Adhere to study-specific Data Management Plan (DMP).
Create and enter test data for User Acceptance Testing (UAT) across different study roles.
Review lab normal ranges and perform discrepancy (edit check) outputs.
Handle Data Clarification Forms (DCFs) for paper studies; perform internal QC checks.
Conduct DM quality reviews for EDC studies.
Participate/lead internal meetings, in-process review meetings, audits, and inspections.
Manage study file documentation in Data Management Study File (DMSF).
Perform SAS mapping QC, post-migration testing, and reconciliations of external datasets (lab, PK, IRT, eDiary).
Run data cleaning/status reports, perform SAE reconciliations, and create ad-hoc data cleaning reports.
Review database design specifications (CRF/eCRF, visit structure, DVS/edit checks).
Provide support to PDM and may serve as backup for specific activities.
Train and mentor DM staff, conduct EDC training, and serve as platform/process Subject Matter Expert (SME).
Ensure adherence to corporate practices, SOPs, and working instructions.
Qualifications:
BA/BS degree in biological sciences or related health/natural science disciplines
5+ years of experience in external data handling
Client-facing experience required
Proficiency with P21 standards, eCOA, ePRO, Microsoft Office Suite
Familiarity with medical terminology and clinical research processes
Knowledge of clinical trial process (Phases II-IV) and ICH GCP guidelines
Strong organizational, planning, and time management skills
Excellent communication, presentation, and interpersonal skills
Leadership, mentoring, and training experience in data management
Additional Requirements:
Ability to multitask under tight deadlines and adapt to changing priorities
Ability to work independently and in a multidisciplinary team
Minimal travel required (up to 25%)
Impact & Contribution:
Lead other Clinical Data Associates in all data management activities.
Support Project Data Manager (PDM) as needed.
Ensure high-quality data management deliverables for global clinical trials.
Company Highlights:
Worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products
Supported 200+ studies across 73,000 sites and 675,000+ trial patients
Website: Syneos Health
Job Category:
Clinical Data Management / Data Operations / Clinical Operations
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