Lead Clinical Operations

Lead Clinical Operations 
Dr. Reddys foundation - Hyderabad

Oversee and Manage Contract Research Organizations (CROs) in the conduct of outsourced multi-national clinical trials. Oversee the Investigational Product management and budgeting for clinical trials. Manage clinical study monitors and interact with investigational sites. Track enrollment and patient participation on multiple clinical trials (globally). Clinical Data Management Review clinical database and reports prepared by team before submission to regulatory authorities. Guide and review preparation of manuscript for submission of publications to national/international journals and conferences. Review monitoring reports submitted by monitoring personnel. Manage the transfer of information and documents between Sponsor and Contract CRAs, and Sponsor and Investigational Sites. Liaison Managing project teams internally and at CRO for deliverables. Liaison internally with various related departments (viz. Manufacturing, QA, RA). Represent the sponsor in Regulatory Audits (FDA/EMA/National/DCGI) of CRO for global clinical trials. For more info visit at mentioned link