The Medical Writer creates and reviews clinical and safety documents, including aggregate reports, risk management plans, and clinical study reports to support product development. They also collaborate with cross-functional teams and regulatory agencies to ensure compliance with pharmacovigilance standards.
The Medical Writer creates and reviews clinical and safety documents, including aggregate reports, risk management plans, and clinical study reports to support product development and regulatory compliance. They also collaborate with safety teams, perform signal assessments, and provide mentorship to pharmacovigilance associates.
The Senior CRA serves as the primary point of contact for clinical trial sites, managing the full lifecycle from start-up to closeout. They are responsible for monitoring site compliance with protocols and ICH-GCP, ensuring data integrity, and overseeing site-level activities.
The Medical Director provides strategic input for clinical projects and manages medical monitoring for clinical trials. They are responsible for supporting site investigators, reviewing data, and ensuring compliance with FDA regulatory requirements.
The Medical Director will provide strategic input into clinical projects, manage medical monitoring, and support site investigators throughout clinical trials. They are responsible for data review, medical writing for protocols and reports, and ensuring compliance with FDA interactions.
The Vice President, Commercial will lead and unify revenue growth across Sitero's eClinical technology and full-service clinical operations businesses. This role involves defining go-to-market strategies, managing global revenue targets, and building a high-performing commercial team.
The member reviews research protocols and monitors regulatory compliance to ensure the protection of participants, animals, and biosafety standards. They provide recommendations for the approval or termination of studies and assess risks associated with hazardous biological work.
