Clinical Data Associate III at Syneos Health
About Syneos Health: Syneos Health is a globally integrated biopharmaceutical solutions company focused on accelerating client success. By translating clinical, medical, and commercial insights into tangible outcomes, Syneos Health addresses the complexities of the modern healthcare environment. With 29,000 employees across 110 countries, the company is committed to simplifying clinical development and creating a collaborative work culture that drives innovation and accelerates the delivery of life-changing therapies.
Job Responsibilities:
Project Management & Communication:
Maintain awareness of project scope, contract elements, and provide regular status updates to project management.
Ensure adherence to study-specific Clinical Data Management Plans (CDMP).
Perform User Acceptance Testing (UAT) for data entry screens, validation listings, and Targeted Source Data Verification (SDV).
Data Review & Validation:
Review discrepancy outputs, perform data validation checks, and resolve or query discrepancies based on project specifications.
Perform quality control (QC) checks for both electronic data capture (EDC) and paper-based studies.
Review and edit Data Clarification Forms (DCFs) and manage database updates for paper studies.
Validate external data from labs, electronic diaries, pharmacokinetics (PK), or Interactive Response Technology (IRT).
Training & Coordination:
Coordinate tasks among Clinical Data Associates (CDAs) and provide training on data management activities and systems.
Participate in internal and external audits and meetings to provide updates and ensure data quality.
Reporting & Documentation:
Generate data cleaning and status reports.
Perform Serious Adverse Event (SAE) reconciliations.
Create and update the Data Management Plan and other relevant documentation.
Technical Expertise:
Perform SAS mapping QC and create ad-hoc data cleaning reports.
Participate in post-migration testing and ensure compliance with Data Validation Specifications (DVS).
Review and provide input into CRF/eCRF design and data validation specifications.
Qualifications:
Education:
BA/BS degree in biological sciences or a related healthcare field.
Experience:
Proficiency in Data Management practices, relational database management software, and systems (Oracle Clinical, Rave, or INFORM preferred).
Experience in clinical research, drug development, and data management is preferred, especially in oncology trials.
Skills:
Strong understanding of ICH/Good Clinical Practices (GCP) and medical terminology.
Proficiency in MS Windows, Word, Excel, and email applications.
Excellent communication skills, with the ability to influence and persuade both verbally and in writing.
Additional Attributes:
Ability to multitask under tight deadlines and manage competing priorities.
Flexibility to adapt to changes and work independently or in a team.
Willingness to travel up to 25%.
Why Syneos Health?
Career Development:
Syneos Health is committed to the professional growth of its employees through continuous career development, training, and recognition.
Inclusive Culture:
The company fosters a “Total Self” culture, where employees can bring their authentic selves to work and contribute to a diverse and inclusive environment.
Global Impact:
Syneos Health has supported the development of 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, making a significant impact on global healthcare.
Additional Information:
The company reserves the right to assign additional duties or modify responsibilities as needed. Syneos Health is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations to assist employees in performing their roles.
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