Senior Manager, Risk Based Quality Management

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Manage scientific operations, ensuring a balance between quality, timelines, and stakeholder expectations.

• Design and oversee clinical risk management strategies, which encompass risk assessment, mitigation planning, and monitoring.

• Lead a team in recognizing potential risks associated with clinical trial operations, data integrity, and patient safety.

• Implement robust risk management measures.

• Collaborate with teams in clinical operations, regulatory affairs, and data management.

• Monitor and analyze data and trends related to risk.

• Offer insights and recommendations to senior management.

• Ensure adherence to regulatory standards and industry best practices, including Good Clinical Practice (GCP).

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Medicine, Risk Management, or a related discipline.

• Significant experience in clinical risk management or related positions, with a strong focus on assessing and mitigating risks in clinical trials.

• Demonstrated leadership abilities, with experience in managing and developing a team dedicated to risk management and patient safety.

• In-depth knowledge of regulatory requirements, industry standards, and risk management methodologies, along with a solid grasp of clinical trial operations.

• Exceptional analytical and problem-solving skills, with the capacity to provide strategic recommendations and effectively communicate risk-related insights to stakeholders.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.