Research Analyst

QPS Bioserve; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

QPS Bioserve in Hyderabad, India seeks a qualified professional to manage study protocol synopsis prep, clinical protocol preparation, and pharmacology input reviews within regulatory frameworks. The role covers study reports, bio summary tables, and CRS-related guideline reviews.

You will dispense responsibilities across pharmacy activities for investigational products, IP handling, and ensuring procedures in the pharmacy align with trial protocols, with emphasis on compliance and accurate

Responsibilities

• 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 consent form.
• Preparation of and review of Clinical Study Reports 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.
• 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.

Job description

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.