his job opportunity as a Central Clinical Research Associate (CRA) – Registries at Sanofi in Hyderabad appears to be a comprehensive role requiring a strong background in clinical research and monitoring. It involves responsibilities across feasibility, start-up activities, site management, data management, quality assurance, and stakeholder collaboration. Here are key highlights:
Role Overview:
- Type: Permanent, Full-time
- Location: Hyderabad, India
- Travel: As needed
Key Responsibilities:
- Feasibility & Site Selection: Participate in site selection with the Registries Team.
- Study Start-Up: Handle collection and review of site documents for regulatory submissions, ensure informed consent customization, and file documentation in eTMF.
- Site Monitoring: Conduct remote and occasional onsite visits for study initiation, monitoring, and close-out.
- Data Management: Review eCRF completeness, resolve data queries, and coordinate data collection projects.
- Site Management: Oversee patient recruitment, site facilities, staff training, and safety reporting.
- Quality Control: Ensure compliance with Good Clinical Practice (GCP) and audit readiness, implement corrective actions as needed.
- Administrative Duties: Maintain trackers, participate in investigator meetings, and manage the investigator payment process.
Required Experience:
- Experience: Minimum of 3+ years in clinical research, including trial monitoring. Experience with rare diseases or real-world evidence studies is advantageous.
- Skills: Attention to detail, problem-solving, project management, technical writing, global project experience.
- Technical Knowledge: Proficient in GCP, regulatory guidelines (FDA, EMA), data management, and medical terminology.
- Education: Degree in pharmaceutical sciences or a life science-related field.
- Language: Proficiency in English (spoken and written).
Soft Skills:
- Effective communication, adaptability, interpersonal skills, ethical judgment, and time management.
