Roles & Responsibilities:
• Design and configure clinical databases using EDC systems such as Oracle Clinical and Medidata Rave.
• Develop Case Report Forms (CRFs) aligned with formulation-specific clinical endpoints.
• Perform data cleaning and query management, resolving discrepancies with clinical sites.
• Conduct User Acceptance Testing (UAT) to validate database logic and edit checks.
• Ensure data accuracy, consistency, integrity, and traceability throughout the clinical study lifecycle.
• Support database lock activities and clinical data transfer to biostatistics teams.
• Provide submission-ready clinical data to support global regulatory filings and formulation performance evaluation.
• Collaborate with clinical, formulation R&D, and regulatory teams to ensure compliant data management practices.
Qualification:
• M.Pharm (Clinical) – Mandatory.
Experience:
• 2–5 years of experience in Clinical Data Management or Clinical R&D.
Skills:
• Hands-on experience with EDC systems (Oracle Clinical, Medidata Rave, or equivalent).
• Strong understanding of GCP guidelines and clinical trial workflows.
• Working knowledge of CDISC standards (SDTM/ADaM) preferred.
• Excellent communication and cross-functional coordination skills.
• Strong attention to detail and data quality mindset.
About the Organization:
Bachwell Pharma is a growing pharmaceutical company with a strong focus on formulation R&D for global regulatory markets. The organization supports development of tablets, injectables, and topical formulations, offering professionals the opportunity to work at the intersection of clinical research, data management, and regulatory submissions in a dynamic R&D environment.
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