Clinical Data Associate I (Inform EDC) - India-Asia Pacific - IND-Home-Based
Job ID: 25002255
Updated: Today
Description:
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical, and commercial insights into outcomes. Our Clinical Development model centers around the customer and patient, streamlining our work to ensure we are easy to work with and for.
Why Syneos Health:
Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic area training.
Recognition through peer and rewards programs.
Total Self culture that values diversity, inclusion, and belonging.
Job Responsibilities:
Maintain awareness of contract and scope of work for assigned projects.
Adhere to study-specific Clinical Data Management Plans.
Enter lab normal ranges and submit CDMS-specific access forms.
Review discrepancy output and validation listings for clinical database data.
Apply self-evident corrections and resolve queries appropriately.
For paper studies:
Review Data Clarification Forms (DCFs) and edit Case Report Forms (CRFs).
Perform internal QC checks and file all documents per guidelines.
For EDC studies:
Perform DM quality reviews and QC checks.
Assist in tracking project progress and issue status reports.
Participate in database finalization and document transfer to sponsors.
Create electronic storage media per SOPs for EDC studies.
Participate in internal/external audits as required.
Maintain proficiency in DM systems and processes through regular training.
Qualifications:
BA/BS degree in biological sciences or related disciplines.
Experience with DM practices and relational database management preferred.
Inform systems experience preferred.
Knowledge of clinical data, ICH/Good Clinical Practices, and medical terminology.
Proficiency in MS Windows, Word, Excel, and email applications.
Strong keyboard skills with accuracy and speed.
Work experience in clinical research, drug development, or healthcare preferred.
Excellent communication, interpersonal, and organizational skills.
Ability to multitask, adapt to change, and work independently or as part of a team.
Compliance with Corporate Business Practices and SOPs.
Minimal travel may be required (up to 25%).
Additional Information:
Tasks, duties, and responsibilities may be adjusted at the company’s discretion. Equivalent experience, skills, and education will be considered where appropriate. The Company is committed to compliance with relevant legislation, including providing reasonable accommodations under the Americans with Disabilities Act.
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Japan | Saitama |Tokyo :
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