Role & responsibilities:

Study Synopsis Preparation

- Preparation and Compilation of study Protocol Synopsis.

- Preparation and review of Clinical Study Protocols as per sponsor and/or applicable regulatory authorities.

- Preparation of informed consonant form.

Clinical Protocol Preparation

- Preparation of and review of Clinical Study Reports as per sponsor and/or applicable regulatory authorities.

- Preparation and review of Clinical study report as per sponsor and/or applicable regulatory authorities.

- Preparation and review of Bio Summary Tables/ clinical Summaries/CSBE for different regulatory submissions.

- Responsible for designing and reviewing scientific and technical inputs for pharmacokinetic and pharmacodynamics studies.

- Responsible for reviewing regulatory guidelines with the current requirements for CRS related activities.

Pharmacy Activities

- Responsible for dispensing the investigational drug products as per the randomization schedule Bioavailability / Bioequivalence Studies.

- Issuing IPs to Clinical Unit before dosing and collecting unused IPs and stored in pharmacy.

- Review procedures for pharmacy operations.

Preferred candidate profile: can send the CV to [email protected]

📌 Research Analyst (Hyderabad)
🏢 QPS Bioserve
📍 Hyderabad