Kashiv Pharma, LLC is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.
Provides Strategic and Operational Leadership of clinical research studies to ensure delivery on time, within Budget and high quality in compliance with ICH-GCP, Regulatory Authorities, guidelines and applicable SOPs. Responsibilities include Clinical study monitoring, Preparation of SOPs, Providing inputs on study designs, operational directions of one or more cross functional study teams, and quality oversight of one or more Clinical sites/SMOs/Specialty CROs. Responsibilities involve combination of execution and oversight to ensure deliverables. Develop and Maintain collaborative relationship with internal teams including Clinical Operational teams, Project Management teams and affiliates external partners including specialty CROs, SMOs, Clinical Sites, Principal Investigators, Academic Research Organizations and other clinical service providers.
Communication and other Skills: