Syneos Health CDM Jobs – BSc Biological Sciences Apply Online
CDA II
Location: India-Asia Pacific – IND-Home-Based
Job ID: 24006411
Description
Clinical Data Associate II
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We leverage unique clinical, medical affairs, and commercial insights to achieve impactful outcomes in today’s market.
Our Clinical Development model prioritizes customers and patients, streamlining processes to enhance our work environment and results. Whether in a Functional Service Provider partnership or a Full-Service environment, our team of passionate problem solvers collaborates to drive innovation and deliver therapies that change lives.
Why Syneos Health
- Career development and progression opportunities.
- Supportive line management, technical training, and therapeutic area education.
- A Total Self culture fostering authenticity and belonging.
- Diversity and inclusion, promoting unity through diverse thoughts and perspectives.
Job Responsibilities
- Maintain awareness of the contract and scope of work for assigned projects.
- Review and adhere to study-specific Clinical Data Management Plans (DMPs).
- Create and enter test data for User Acceptance Testing (UAT).
- Perform UAT for data entry screens, edits, and review listings.
- Receive and enter lab normal ranges.
- Complete Clinical Database Management System (CDMS)-specific access forms or spreadsheets.
- Review discrepancy output and validation listings; query or apply corrections per Data Validation Specifications (DVS) and DMP.
- Resolve answered queries and re-query if necessary.
- For paper studies:
- Review and process Data Clarification Forms (DCFs).
- Edit Case Report Forms (CRFs) and databases accordingly.
- Perform internal QC checks and serve as QC Coordinator.
- File CRFs and DCFs per Data Tracking Guidelines.
- For EDC studies:
- Conduct DM quality review and internal QC checks.
- Create electronic storage media per SOPs.
- Participate in meetings and audits.
- File documentation in the Data Management Study File (DMSF).
- Maintain proficiency in systems and processes through regular training.
- Create and enter test data for Standard Data Tabulation Model (SDTM).
- Perform SAS mapping QC and document discrepancies.
- Coordinate and train CDAs, as needed.
- Reconcile data from external databases (e.g., lab data, diary data, pharmacokinetic data).
- Run data cleaning and status reports.
- Perform Serious Adverse Event (SAE) reconciliations.
- Understand coding processes and interim/dry-run data cuts.
- Proactively manage tasks, prioritize workload, and adapt to timeline changes.
Qualifications
- BA/BS degree in biological sciences or related fields.
- Experience in data management practices and relational database systems preferred.
- Familiarity with Oracle Clinical, Rave, or Inform systems is an advantage.
- Knowledge of clinical data, ICH/Good Clinical Practices, and medical terminology preferred.
- Proficiency in MS Windows, MS Word, Excel, and email applications.
- Strong keyboard skills with excellent speed and accuracy.
- Preferred work experience in clinical research, drug development, or data management.
- Excellent communication, presentation, and interpersonal skills.
- Strong organizational, planning, and time management skills.
- Ability to multitask under deadlines, with attention to detail and adaptability.
- Comfortable working independently or as part of a multidisciplinary team.
Other Details
- Compliance with Corporate Business Practices, SOPs, and Working Instructions.
- Additional duties as assigned by management.
- Minimal travel may be required (up to 25%).
Keywords: Syneos Health, Clinical Data Associate, CDA II, Biopharmaceutical Solutions, Clinical Development, Integrated, Healthcare, Clinical Data Management, Oracle Clinical, Rave, Inform, ICH/GCP, Medical Terminology, Data Management, Data Entry, Clinical Research, Drug Development. Syneos Health CDM Jobs – BSc Biological Sciences Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
