Job description
Role & responsibilities:
Clinical Protocol Preparation
- Carrying Literature survey to provide scientific inputs for protocols and study Reports.
- Preparation and Compilation of study proposal Synopsis for Pharmacodynamics, Pharmacokinetic and BA/BE studies.
- Responsible for research, create, edit and coordinate the preparation and review of clinical study protocols.
- Provide guidance and scientific direction for creative designs and input into study protocols as appropriate.
- Responsible for development and delivery of scientifically accurate protocol content that is aligned with study objectives and meets the specification of the sponsor.
- Identification and development of clinical study designs as per current global customer requirements.
Pharmacy
- Responsible for receipt of drug for Bioavailability/Bioequivalence and Clinical Trial Studies.
- Maintenance of drug products in the pharmacy as per the product specific storage condition.
- Responsible for dispensing the investigational drug products as per the randomization schedule for Bioavailability/Bioequivalence and Clinical Trial Studies.
- Responsible for archival and/ or disposition of investigational drug products as per the protocols and/or sponsor requirement.
- Review procedures for pharmacy operations.