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. The company aims to streamline clinical, medical affairs, and commercial insights into effective outcomes that address modern market challenges. Syneos Health operates with a customer and patient-centric approach, continually innovating to deliver therapies that change lives. With over 29,000 employees across 110 countries, Syneos Health helps drive the delivery of cutting-edge therapies.
Job Responsibilities:
Data Management:
Maintain awareness of contract and scope for assigned projects and provide status updates to the Project Manager.
Review and adhere to study-specific Clinical Data Management Plans.
Enter test data for User Acceptance Testing (UAT) and perform testing on various data entry systems and edit checks.
Perform quality checks and validation on discrepancy outputs, data clarification forms (DCFs), and CRFs.
Conduct internal QC checks for paper studies and ensure proper documentation for all data.
Data Cleaning & Validation:
Review data entered into the clinical database and resolve discrepancies.
Query, apply self-evident corrections, or escalate issues based on the Data Validation Specification or Data Management Plan.
For EDC studies, ensure proper quality review of data and conduct SAS mapping QC checks.
Create and update data cleaning reports and validated listings.
Project Support & Coordination:
Coordinate work for other Clinical Data Associates (CDAs) on the project and provide training as needed.
Participate in internal meetings, external audits, and sponsor meetings to ensure proper data management practices.
Support the Data Manager by updating documents such as the Data Management Plan and Data Transfer Request Form.
Reporting & Documentation:
Run data cleaning and status reports.
Perform Serious Adverse Event (SAE) reconciliations.
Maintain the Data Management Study File (DMSF) and assist in the preparation of other relevant project documentation.
Review and create CRF/eCRF completion guidelines.
Regulatory Compliance & Communication:
Ensure all tasks are performed in compliance with applicable Corporate Business Practices, Standard Operating Procedures (SOPs), and Working Instructions.
Facilitate communication between the project team, sponsors, and third-party vendors, ensuring accurate and timely distribution of relevant information.
Qualifications:
Education:
BA/BS in biological sciences or a related healthcare field.
Experience:
Experience with data management practices and relational database management systems, especially Oracle Clinical, Rave, or Inform.
Familiarity with clinical data, ICH/Good Clinical Practices (GCP), and medical terminology.
Prior experience in clinical research or data management is preferred.
Skills:
Proficiency in MS Windows and tools like MS Word, Excel, and email applications.
Excellent communication, organizational, and time management skills.
Ability to multitask and adapt to changing deadlines and priorities.
Ability to work both independently and as part of a team.
Additional Requirements:
Ability to handle minimal travel (up to 25%).
Understanding of the coding process and data validation procedures.
Flexibility to adapt to change and new challenges.
Why Syneos Health?
Career Development:
Syneos Health is dedicated to fostering employee growth through career progression, training, and recognition programs.
Inclusive Culture:
The company is committed to maintaining a Total Self culture, celebrating diversity and creating a workplace where everyone belongs.
Global Impact:
Syneos Health partners with industry leaders to develop and deliver therapies that change the lives of patients worldwide.
Additional Information:
Tasks, duties, and responsibilities outlined in this job description are not exhaustive. The company may assign other tasks as necessary. Equivalent experience, skills, and education may be considered in place of the qualifications listed. The company is committed to complying with all relevant employment laws and providing accommodations as needed for employees with disabilities.
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