Safety Specialist
AdaMarie · New Jersey, United States · Today
ManagementFull-time
About the role
Individual contributor that works under limited supervision. Applies subject matter knowledge. Requires capacity to understand specific needs or requirements to apply skills/knowledge.
Responsibilities
- Plans, directs, creates and communicates clinical study timelines.
- Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule.
- Ensures consistency of clinical study and processes across clinical trials.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets.
- Ensures study is conducted within clinical trial protocols.
- Monitors progress and follows up with team members and line managers when issues develop.
Qualifications
Education Level: Associates Degree (± 13 years) or equivalent major/field of study.
Experience/Background: Minimum 1 year.