Clinical Data Associate III at Syneos Health
About Syneos Health:
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. They leverage clinical, medical affairs, and commercial insights to deliver outcomes that address modern market challenges. With 29,000 employees in over 110 countries, Syneos Health is passionate about transforming clinical development by simplifying processes, enhancing collaboration, and driving the delivery of life-changing therapies.
Job Responsibilities:
Data Management:
Ensure awareness of the contract and scope of work for assigned projects.
Review and adhere to Clinical Data Management Plans (CDMP) for studies.
Perform User Acceptance Testing (UAT) for data entry screens, edit checks, and data review listings.
Perform data entry, validation, and data review, including discrepancy resolution.
Quality Control & Validation:
Conduct quality control checks for both electronic and paper studies, ensuring accurate data and file documentation.
Perform reviews of data discrepancy outputs, validation listings, and SAS mapping QC.
Manage data discrepancies, querying and applying corrections per study guidelines.
Coordination & Support:
Coordinate tasks for Clinical Data Associates (CDAs) on the project and provide training as needed.
Participate in internal and external meetings, ensuring all relevant information is distributed to the project team.
Maintain regular communication regarding task status, timelines, and prioritization.
Reporting & Documentation:
Run status reports, data cleaning reports, and manage Serious Adverse Event (SAE) reconciliations.
Create and maintain data management documentation including study files, reports, and transfer forms.
Support Data Managers in the preparation of Data Management Plans and other related documents.
Technical and Regulatory Knowledge:
Collaborate with other departments such as Safety, Biostatistics, and Clinical Programming for data consistency.
Provide input into the Data Validation Specification (DVS) and contribute to the creation of edit checks.
Understand the purpose of interim data cuts and post-production updates.
Qualifications:
Education:
BA/BS degree in biological sciences or related healthcare fields.
Experience:
4-6 years of experience in Clinical Data Management, including query management, vendor reconciliation, and data migrations.
Experience with EDC systems like Veeva, RAVE, or INFORM is preferred.
Experience in oncology trials is an advantage.
Technical Skills:
Proficiency in MS Windows, Word, Excel, and email applications.
Hands-on experience with Oracle Clinical, RAVE, or INFORM systems.
Familiarity with medical terminology and clinical research practices.
Soft Skills:
Strong communication, organizational, and time management skills.
Ability to multitask under tight deadlines and adapt to changing project requirements.
Capability to work both independently and collaboratively in a multi-disciplinary team.
Other Requirements:
Minimal travel (up to 25%).
Ability to perform tasks in compliance with corporate practices, SOPs, and working instructions.
Why Syneos Health?
Career Development:
Syneos Health is dedicated to fostering employee growth with opportunities for career progression, peer recognition, and technical training.
Inclusive Culture:
The company is committed to maintaining a Total Self culture, celebrating diversity, and providing a place where everyone feels like they belong.
Global Impact:
Syneos Health has been involved in the development of 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across more than 70,000 sites.
Additional Information:
Tasks, duties, and responsibilities may evolve over time. The company reserves the right to assign additional tasks or adjust job requirements. Syneos Health also complies with all applicable employment regulations and provides accommodations for employees with disabilities.
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