Senior Manager, Clinical Scientist

Remotefull timeRemote

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senior

$159k–$206k

H1B: yes

Replimune Senior Manager, Clinical Scientist at Replimune responsible for executing clinical development programs and deliverables in partnership across the organization and external collaborators. Supports clinical study design, implementation, and documentation.

Responsibilities

Facilitate and execute the creation, update, and/or review of key clinical and regulatory documents, including, but not limited to:
o Protocol concepts, synopses, protocols, and amendments
o Informed consent documents
o Investigator Brochures
o Clinical study reports
o Abstracts, posters, and manuscripts
o Clinical sections of INDs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
o Clinical study supporting documentations and processes, e.g.: charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc.
Supports all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical studies. Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following:
o Provide clinical and scientific expertise for selection for investigator/site staff and vendors
o Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
o Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs