Senior Clinical Safety Specialist - Remote / Telecommute

Cynet Systems Inc; Minnetonka (MN); Remote; USD 80,000 - 110,000; Full time

Job summary

An innovative staffing and recruiting firm is seeking a Senior Clinical Safety Specialist to join their remote team. This role involves managing adverse event processing and ensuring patient safety through compliance with quality policies. You will work collaboratively with clinical teams to author safety documents and conduct safety reviews, playing a crucial role in clinical trials. If you have a strong background in clinical safety and a passion for patient care, this is an exciting opportunity to contribute to meaningful projects in a dynamic environment.

Qualifications

• 5+ years of clinical trial experience in a safety role.
• Proven experience with clinical trial safety processes.

Responsibilities

• Manage adverse event processing and ensure compliance with safety protocols.
• Conduct Clinical Trial Safety Review meetings and manage deliverables.

Skills

Adverse Event Processing

Clinical Trial Safety Processes

Medical Narrative Writing

Project Management

Education

Bachelor’s degree in a science-related field

Tools

Clinical Databases

Job description

Senior Clinical Safety Specialist - Remote / Telecommute

Pay: Competitive

Employment type: Full-Time

Job Description

• Req#: 25-32545
• Responsibilities:

• Manage adverse event processing, including report review, safety query management, and expedited reporting.
• Assess the type and level of processing required for adverse events.
• Author study-specific safety documents and plans (e.g., safety plan, CEC/IMR Charter).
• Act as a member of the clinical core team.
• Conduct Clinical Trial Safety Review meetings.
• Ensure adjudication and reconciliation of safety events are completed prior to data snapshots.
• Provide safety-related input to other study documents/processes as requested (e.g., protocol, CRF design).
• Manage functional deliverables to ensure study milestones are met.
• Manage additional projects, deliverables, and timelines within the clinical department.

Quality System

• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Required Qualifications

• Bachelor’s degree or equivalent experience in a science-related field.
• Minimum 5 years of clinical trial experience in a safety role.
• Proven experience with clinical trial safety processes.
• Background in medical devices.

Preferred Qualifications

• Therapeutic knowledge in Urology.
• Knowledge of GCP guidelines.
• Experience with processing safety events and medical narrative writing.
• Familiarity with clinical databases and systems.

About the company

We are a team of technical visionaries committed to gathering the brightest talent to help organizations realize their technological goals. Welcome to Cynet Systems Inc., a premier staffing and recruiting firm that is nationally and locally certified as a diversity employer.