Senior Associate Study Manager

A company is looking for a Senior Associate Study Manager.

Key Responsibilities

Support the execution and monitoring of clinical studies and trial deliverables

Assist in the preparation, writing, and review of study-related documents

Coordinate site start-up activities and manage study budgets and timelines

Required Qualifications

Master's degree, or Bachelor's / RN with 3+ years of experience, or Associate's with 6+ years, or High School diploma with 10+ years in a life sciences or medically related field

Knowledge of ICH, GCP, FDA regulations, and international regulatory standards

Experience interacting with external vendors such as CROs and contract labs

Skilled in project planning and oversight of study deliverables, budgets, and timelines

Proficient in developing site-selection criteria and applying scientific knowledge to study designs