Are you passionate about clinical research and data management? Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is hiring for the role of Clinical Data Associate I. This is a home-based position in India, offering you the flexibility to work remotely while contributing to groundbreaking clinical trials. If you have 1-2 years of experience in clinical data management and a strong understanding of EDC tools like Rave, this could be the perfect opportunity for you.
Job Description
As a Clinical Data Associate I at Syneos Health, you will play a critical role in ensuring the accuracy and integrity of clinical trial data. Your responsibilities will include:
- Data Review and Validation: Review discrepancy outputs, resolve queries, and apply self-evident corrections as per the Data Validation Specification (DVS) and Data Management Plan (DMP).
- Database Management: Perform quality checks on clinical databases, ensuring compliance with study-specific requirements.
- Documentation: File and maintain study-related documents in the Data Management Study File (DMSF) and assist with study archival.
- Collaboration: Work closely with cross-functional teams to track project progress, issue status reports, and ensure timely database finalization and transfer to sponsors.
- Compliance: Adhere to corporate business practices, SOPs, and regulatory guidelines, including ICH/GCP standards.
- Training: Stay updated on data management systems and processes through regular training programs.
Qualifications
To excel in this role, you should have:
- A BA/BS degree in biological sciences, natural sciences, or a related healthcare field.
- 1-2 years of experience in clinical data management, with proficiency in Rave EDC tools.
- Familiarity with Oracle Clinical, Inform, or similar relational database management systems.
- Knowledge of medical terminology and therapeutic areas such as Oncology, Cardiology, Immunology, or Gastrointestinal (GI).
- Strong organizational, communication, and multitasking skills.
- Proficiency in MS Windows, Word, Excel, and email applications.
Why Syneos Health?
Syneos Health is a global leader in clinical research, working on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. Here’s why you should join us:
- Career Growth: We are passionate about developing our people through career progression, training, and peer recognition.
- Inclusive Culture: Our Total Self culture encourages authenticity and belonging, fostering a diverse and supportive work environment.
- Impactful Work: Contribute to accelerating the delivery of life-changing therapies and improving patient outcomes.
