Remote Senior Risk Manager, Clinical Solutions

Syneos Health, Inc.; Hinoba-an; On-site; PHP 1,188,000 - 1,584,000; Full time

Job summary

Syneos Health is seeking a Senior Risk-Based Monitoring professional to define monitoring strategies, assess risks, and collaborate across functional teams. The role involves leading risk reviews, ensuring data integrity, and mentoring colleagues to enhance project delivery in a remote, globally oriented environment.

The candidate will guide cross-functional teams, ensure alignment with ICH/GCP standards and GPP, and participate in risk-based monitoring oversight across studies, with travel up

Qualifications

• Bachelor’s degree or RN required.
• Master's degree or health data sciences preferred.
• Expert in GCP/ICH E6 (R2) guidelines and regulatory requirements.

Responsibilities

• Provides advice and SME for monitoring strategy development and updates during the study.
• Advises cross-functional leads to ensure consistency in programs and sponsors.
• Drafts initial risk assessment and supports finalization of the RACT.
• Ensures risk transfers to correct tracking systems and supports cross-functional reviews.
• Develops functional plans to mitigate identified risks and ensures data integrity.
• Assesses tools for remote data review and centralized monitoring; identifies data quality risks.
• Facilitates review of findings with cross-functional teams and sponsor; requires leadership input.
• Collaborates to identify Quality Tolerance Limits with Sponsor and team members.
• Delivers training on risk assessment, centralized monitoring, and risk-based monitoring strategies.
• Mentors peers in delivery, risk evaluation and action implementation.
• Works across functions to ensure compliance with protocol, ICH/GCP and GPP, including medical monitoring and QA.
• Understands study scope, budget, and protocol; escalates risks to PM.
• May participate in business development activities including monitoring strategy and budget input.

Skills

GCP/ICH E6(R2)

Risk-Based Monitoring

IQRM theories

Clinical monitoring

Data visualization

Education

Bachelor’s degree or RN

Master’s degree preferred

Tools

Cluepoints

Medidata-CSA

Hy's Law

Job description

Syneos Health is seeking a Senior Risk-Based Monitoring professional to define monitoring strategies, assess risks, and collaborate across functional teams. The role involves leading risk reviews, ensuring data integrity, and mentoring colleagues to enhance project delivery in a remote, globally oriented environment.

The candidate will guide cross-functional teams, ensure alignment with ICH/GCP standards and GPP, and participate in risk-based monitoring oversight across studies, with travel up