- Approximately 10+ years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality and timeline

- Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans

- Leverage appropriate on-going data review to identify and mitigate patient safety, study design, data integrity or study conduct issues

- Ensure all operational aspects support end point integrity and data validity.

- Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease, or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan

- Contributing to a clinical development plan within a program moving into a new or subdivision of a current indication.

- Building a rich knowledge of specific Area(s) of Expertise within a phase.

- Utilizing operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options and ensure the successful execution of study(ies).

- MS in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills.

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