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 (India)
🏢 Veeda CR
📍 India