• Quality check clinical trial protocol and provides input for the same.• Identify data discrepancies,raising data clarification form and resolving the queries raised by Quality Assurance department.• Quality check of protocol specified inclusion/exclusion criteria,physical Examination forms and all other source documents and confirms the eligibility of subjects for studies• Ensures that the informed consent process has been followed,properly documented,and filed as required.• Assures compliance with protocol details,completes necessary records,and coordinates the scheduling of subjects and monitoring visits.• Accurately check source documentation and case report forms within the timelines for completeness and accuracy and is familiar with all records required for each study.• Collaborates with the study staff to ensures that the tests and procedures requiredBy clinical protocols are performed and documented.• Quality check of study reports.• Monitoring of informed consent process,PK Sampling,Dosing of the study medication,Recording of vitals,sample separation process,sample transfer and all other study related activities.• Coordinating for the monitoring visits,sponsor audits and regulatory audits.• Coordinating for regulatory approval and Ethics committee approval with the respective department.• Coordinating with all the respective departments for the conduct of the study in accordance with GCP,Regulatory guidelines,clinical trial protocol and SOPs• Preparation of FDA Forms for USFDA Submission studies• Communication with sponsors about the periodic clinical study updates • Onsite Monitoring and Quality Control of all BA/ BE study related documents and activities; handling and documentation of ISF, SMF, CRFs etc. • Proactively address issues, finding solutions and to complete project in timelines• Coordinating for conduct of clinical trial activities; reporting of AE, SAE, study progress, Protocol and SOP deviations to the sponsor and IEC

• Responsible link between Sponsor, Principal Investigator, Project management and clinical study site staff. • Onsite Monitoring and Quality Control of all BA/ BE study related documents and activities; handling and documentation of ISF, SMF, CRFs etc. • Proactively address issues, finding solutions and to complete project in Monitoring of Investigational site.• Meeting with Principal Investigator for explaining project details, setting timelines and required target. • Investigational site staff training, Clarification of queries, Trial drug supply.• Communicating timelines Conduct of Site Selection visit, Site Initiation and Close out visits, link between project manager and principal investigator. • Conducting interim monitoring visits to carry out clinical trial with adherence to GCP, SOP, Protocol, and applicable Regulatory Authority• Responsible for proper administration according to the randomization of schedules.• Holding the retention of drug samples of pivotal studies as per the regulatory requirements.• Maintaining proper inventories of IP’s, Logbooks and various forms.• Handling IP’s disposal as per current versions of SOP’s.