Clinical Study Manager
The Clinical Study Manager oversees the planning, execution, and delivery of clinical trials to ensure they are conducted on time, within budget, and in compliance with protocols, GCP, and regulatory requirements. This role serves as the primary point of contact between sponsors, CROs, and study sites.
Responsibilities:
Lead study start-up, execution, and close-out activities
Manage timelines, budgets, and vendor performance
Oversee site selection, initiation, and monitoring
Ensure compliance with protocols, GCP, and applicable regulations
Provide oversight of study team activities and ensure data quality
Track study progress and deliver regular updates to stakeholders
Skills & Experience:
Bachelor’s degree in life sciences or related field; advanced degree preferred
Experience in clinical trial management required
Strong knowledge of GCP, ICH guidelines, and FDA regulations
Excellent leadership, communication, and organizational skills
EEO Employer
We are an equal opportunity employer and comply with all applicable federal, state, and local fair employment practices laws. We strictly prohibit and do not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, sexual orientation, gender (including gender identity and expression), marital or familial status, age, physical or mental disability, perceived disability, citizenship status, service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. Applications from members of minority groups and women are encouraged.