Safety Specialist

Job Description

MAIN PURPOSE OF 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.

MAIN RESPONSIBILITIES
u2022 Plans, directs, creates and communicates clinical study time-lines.
u2022 Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule.
u2022 Ensures consistency of clinical study and processes across clinical trials.
u2022 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.
u2022 Ensures study is conducted within clinical trial protocols.
u2022 Monitors progress and follows up with team members and line managers when issues develop.

QUALIFICATIONS
Education Level Major/Field of Study or Equivalent
Associates Degree (u00B1 13 years)
Experience/Background
Minimum 1 year