Clinical Development Risk & Compliance Manager

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

📋 Description

• Lead, facilitate, and support the risk management process for designated projects, partnerships, and accounts utilizing the available tools.

• Collaborate with other RCLs to supervise and guide the risk management process across various projects within the account.

• Direct cross-functional teams, functional leaders, and subject matter experts (SMEs) in identifying, prioritizing, and mitigating risks, integrating solutions into project strategies.

• Assess and enhance the effectiveness of mitigation strategies, fostering continuous improvement in risk management practices.

• Establish best practices for documenting and sharing lessons learned, promoting a culture of knowledge exchange.

• Provide expert guidance to fellow RCLs and serve as a resource for addressing escalated risk issues.

• Conduct proactive analyses of key risk indicators and signals across projects and accounts through Quality Risk Evaluations (QRE), utilizing dashboards, metrics, and predictive tools.

• Transform complex data into actionable insights, delivering high-level risk assessments and recommendations to project teams and leadership.

• Oversee the development and execution of mitigation strategies, ensuring their long-term success and alignment with organizational objectives.

• Mentor other RCLs on the QRE process and advise leadership on escalated risks.

• Act as a subject matter expert for QRE as designated by LM, serving as a senior consultant on complex consultancy requests and deviations from Standard Operating Procedures (SOPs).

• Provide strategic, real-time guidance to project teams and leadership to ensure first-time quality and address high-impact challenges.

• Lead investigations into project-level SOP deviations across projects and accounts, working with SMEs to propose solutions.

• Collaborate with project teams to maintain an audit/inspection-ready status, offering advanced oversight of storyboards and documentation practices.

• Assist with audit and inspection preparations, prioritizing tasks and reviewing critical documents.

• Coach teams on sustaining audit/inspection readiness as a proactive and continuous priority.

• Identify gaps in documentation proactively, encouraging project teams to document through project-level storyboards where applicable.

• Provide senior-level support during audits/inspections, which may include hosting audits/inspections and managing high-stakes engagements with confidence and expertise.

• Act as the Quality Representative for Quality Events (QE) – addressing quality issues and audit/inspection findings.

• Manage quality issues within the electronic quality management system (eQMS) by setting standards for accuracy and consistency.

• Assist in the initial assessment of Serious Breach of Good Clinical Practice (GCP) and coordinate rapid and effective containment strategies with the QE team.

• Drive Root Cause Analysis (RCA) initiatives using established methodologies, ensuring the development and execution of impactful Corrective and Preventive Actions (CAPAs).

• Evaluate and enhance CAPA effectiveness, providing strategic direction to optimize quality outcomes.

• Review and refine audit/inspection responses before final QA submission, ensuring alignment with quality standards.

• Mentor other RCLs on excellence in audit/inspection as the Quality Representative.

• Demonstrate adherence to company standards, ensuring timely completion of training, timesheets, expense reports, and CV updates according to SOPs.

• Maintain strict compliance with ICH-GCP, company processes, and global regulatory requirements, ensuring seamless continuity of responsibilities during absences and coordinating with leadership for oversight.

• Mentor other RCLs and serve as an integration partner to facilitate induction into the CDRCM team.

• Develop and maintain strategic relationships with internal and external stakeholders, including senior client representatives and third-party vendors, to align risk and compliance priorities.

⛳️ Requirements

• 8-12 years of experience in clinical research.

• Proven experience in Quality or Risk Management activities.

• Expertise in root cause methodologies and the development of CAPAs.

• Demonstrated leadership in mentoring teams and managing complex, multi-project accounts.

• Comprehensive understanding of ICH-GCP principles and their strategic application.

• Proficiency in written and spoken English; additional languages are an asset.

• Bachelor’s Degree required, preferably in life sciences or a health-related discipline, or equivalent experience.

• Advanced degree (master’s degree) in a science, technology, or industry-related discipline is strongly preferred.

🏝️ Benefits

• Health insurance.

• Paid time off.

• Flexible working arrangements.

• Professional development opportunities.