Patient Reported Outcomes Principal Job in Nutley 07110, New Jersey US
The Patient Reported Outcomes (PRO) Principal will lead PRO activities for a therapeutic area and develop global strategies for molecules within a therapeutic area.
He/she will ensure relevant PRO endpoints and study design for registration clinical trial programs fulfill global regulatory agencies and key stakeholders requirements.
The incumbent will contribute to the design, implementation and management of registration clinical trials containing PROs including the development of the PRO sections of study concept documents, study protocols, statistical analysis plans, clinical study reports and other development documents.
He/she will be responsible for identifying PRO instruments and evaluating measurement and psychometric properties of the instruments as well as adapting and validating them for use in different patient populations.
In addition, he/she will work cross-functionally to develop publication plans.
The candidate will also be responsible for managing vendors including scope of work development, contract initiation, project milestones, timelines, deliverables and budgets.
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