Safety Specialist

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

• Plans, directs, creates and communicates clinical study time-lines.
• 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: Required:

• A Bachelor’s degree from an accredited university or college with an academic focus in medicine, pre-medicine, nursing, life science, bioengineering, or a related academic field.

• Minimum two years of clinical research experience.

• Understanding of medical terminology.

• Strong written and verbal communication, interpersonal, presentation and organizational skills. Has the ability to interpret basic safety data to meet deadlines as well as the ability to communicate effectively with all levels of employees.

• The ability to generally work independently but seek guidance when necessary.