Key Qualifications:
Bachelor's degree in Science or a related field
5+ years of Clinical Data Management experience
Solid knowledge of Clinical Research, GCP, and regulatory guidelines
Hands-on experience with EDC systems such as Medidata RAVE, Viedoc, Inform, Medrio, or Zelta
Experience with MedDRA and WHO Drug coding
Knowledge of CDISC/SDTM standards
Excellent communication and organizational skills
Key Responsibilities:
• Lead and coordinate clinical data management activities from study start-up through database lock.
• Design, configure, validate, and maintain EDC databases.
• Develop and review CRFs, Data Management Plans, Edit Check Specifications, and other study documentation.
• Perform data review, query management, coding (MedDRA/WHO Drug), SAE reconciliation, and external data reconciliation (e.g., lab and ECG).
• Collaborate with cross-functional teams and EDC vendors to ensure timely, high-quality deliverables.
• Mentor junior team members and provide data management expertise throughout the study lifecycle.
If you're interested or know someone who would be a great fit, feel free to comment below or send me a direct message.
Contact:
[email protected]
📌 Clinical Data Manager (Bengaluru)
🏢 Inventiv Matrix India
📍 Bengaluru