Team Member - Clinical Operations

Key Responsibilities:

• Identify Investigators/ CRO; conduct feasibility & site selection, site Initiation, Co-monitoring visits for site for PK in patient (early phase studies)

• CRO & multiple study vendor evaluations till selection as per Cipla process

• Conducting Top-line & detailed feasibility by coordinating with multiple CRO vendors within timelines. Preparing feasibility report & proposals comparison, coming with most suitable time/cost estimate as part of new product development process – for different indications & study designs.

• Preparation, review, and compilation of study documents.

• Ensuring proper compliance of the documents with the regulatory guidelines.

• Planning and coordination of investigators meetings (IM); preparation and review of IM material.

• Training to site coordinators; coordination with the sites and CROs to conduct the study as per the protocol and Standard Operating procedures (SOPs) that meet the regulatory guidelines.

• Co-ordination for IMP requirements for study conduct and related documents

• Conducting Monitoring visits to ensure study compliance. (Approx. 50-60% travel may be required.

• Travel % may vary project to project.)

• End to end project management starting from CRO/ Vendor selection till study CSR submission till regulatory.

• Providing end to end Project management support throughout the study cycle till study approval.

• Ensuring timely, accurate, complete collection and submission of study data starting from feasibility till CSR submission to regulatory.

• Cross functional co-ordination across multiple dept within Cipla (Project management, regulatory, R&D, QA, Finance, GSS and legal) for multiple activities / approvals to be coordinated for smooth running of study

• Coordination of 505 b (2) products development and active involvement

• Coordination in biosimilar development program