Qualification – MD (MUST)
Clinical Project Management for both in-House and Out-sourced projects .
– Interaction with various cross functional team for timely execution and filing.
– Identifying various CROs for conduct of studies and doing technical evaluation of their capabilities.
– Routinely follow up with team internally for in-house projects and follow up with CROs for various projects.
– Coordinating with RA, Formulation ,SCM and Packaging and labelling team for timely delivery of drug .
– Identifying various vendors for supporting various clinical studies.
– Identifying the investigators for conduct of study and performing on- site feasibility
– Interact with investigators intermittently during study conduct to understand any recruitment and other challenges and provide suggestions.
– Preparation and Review of study documents (Protocol, ICF, CRF and CSR) to ensure safety, regulatory and ethical compliance
– Resolution of medical and safety related queries from sites and project team.
– Provide assistance to the other team members to resolve the queries from the regulatories and/or the ethics committees.
– Performing on-site SQVs ,SIVs and Site monitoring to ensure quality conduct of trial.
– Providing regular updates to the senior management.
– Presentation on protocol and study conduct, wherever required
– Support clinical team in all activities when required
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