Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into meaningful outcomes. With a commitment to putting the customer and patient at the center of everything they do, Syneos Health creates agile solutions that simplify and streamline processes to deliver therapies faster. With a global presence spanning 29,000 employees in 110 countries, Syneos Health is a dynamic and innovative company that prioritizes change, collaboration, and a passion for improving lives.
Job Opportunity: Clinical Data Associate II
- Job ID: 24006411
- Location: India-Asia Pacific (Home-Based)
Responsibilities in the Job: As a Clinical Data Associate II (CDA II) at Syneos Health, you will play a pivotal role in managing data throughout the clinical trial process. Key responsibilities include:
- Reviewing and adhering to study-specific Clinical Data Management Plans.
- Performing User Acceptance Testing (UAT) for data entry screens, edits, and assigned data review listings.
- Reviewing and resolving discrepancies in data entered into the clinical database.
- Ensuring all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) are correctly processed and submitted.
- Conducting internal QC checks for paper and EDC studies.
- Managing external datasets and ensuring consistency across clinical databases.
- Coordinating work with other Clinical Data Associates (CDAs) and providing training on data management activities.
You will also be responsible for ensuring timely completion of tasks, running data cleaning reports, performing Serious Adverse Event (SAE) reconciliations, and assisting with interim data reviews and data cut processes.
Qualifications: To succeed in this role, candidates should meet the following qualifications:
- Educational Requirements: A BA/BS degree in the biological sciences or related fields in healthcare or natural sciences.
- Experience: Prior experience in clinical research, data management, or a related healthcare environment is preferred. Experience with data management practices and relational database management software is a plus.
- Preferred Knowledge: Familiarity with Oracle Clinical, Rave, or Inform systems. A solid understanding of clinical data, ICH/Good Clinical Practices, and medical terminology.
Skills: The ideal candidate should possess the following skills:
- Technical Skills: Proficiency in MS Windows, MS Word, Excel, and email applications. Excellent keyboard skills with high speed and accuracy.
- Communication Skills: Strong written and verbal communication skills to inform, influence, and persuade effectively.
- Time Management and Organizational Skills: Ability to multitask under tight deadlines, prioritize tasks, and maintain attention to detail. Flexibility to adapt to changes and work independently or as part of a team.
- Problem-Solving Skills: Ability to anticipate issues and proactively communicate with team members and management regarding task timelines, availability, and project progress.
