Key Qualifications

Bachelor's degree in Science or a related field

5+ years of Clinical Data Management experience

Robust 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