Role & responsibilities

- To provide scientific inputs in study designs in the healthy subject as well patient based study protocol and clinical study report.
- To review the literatures and regulatory guidance documents for preparation of study design summary synopsis.
- To provide pharmacokinetic-statistical analysis inputs/write-up in designing of clinical study protocol.
- To estimate the sample size and collection of relevant data for sample size justification.
- Review & data interpretation of preliminary results of the clinical studies and way forward for future studies.
- Review of the Pharmacokinetics and statistical analysis plan documents.
- Resolve the queries/observation raised by QC/QA department in study protocol and related documents.
- To provide technical support and valid scientific justification to resolve study related queries / regulatory queries.
- Compilation of the project data and report as per the sponsors requirement and regulatory submission (as applicable).
- To manage the timelines as per the priority and scheduling of the projects in the department

Minimum Education Qualification

B.Pharm/M.Pharm /M.Sc/Pharm.D

📌 PK Scientist (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad