Parexel logo
Parexel

Parexel is an international biopharmaceutical services organization offering a comprehensive range of solutions to the biotechnology, pharmaceutical, and medical device industries.

Clinical Development Risk & Compliance Manager

Location

South Korea

Posted

3 days ago

Salary

0

Seniority

Lead

Bachelor Degree8 yrs expEnglishGoogle Cloud PlatformSwift

Job Description

Clinical Development Risk & Compliance Manager

Parexel

• Lead, facilitate and support the risk management process for assigned projects/Partnership/accounts using the available tools. • Work with other RCLs to oversee and direct the risk management process across multiple projects within the account. • Lead cross-functional teams, functional leaders, and subject matter experts (SMEs) in identifying, prioritizing, and mitigating risks, embedding solutions into project strategies. • Evaluate and refine mitigation effectiveness, driving continuous improvement in risk management practices. • Establish best practices for documenting and disseminating lessons learned, fostering a culture of knowledge-sharing. • Provide expert guidance to other RCLs and serve as a resource for resolving escalated risk challenges. • Lead proactive analysis of key risk indicators and signals across projects and accounts, through Quality Risk Evaluations (QRE), leveraging dashboards, metrics and predictive tools. • Synthesize complex data into actionable insights, presenting high-level risk assessments and recommendations to project teams and leadership. • Direct the development and implementation of mitigation strategies, ensuring their long-term success and alignment with organizational goals. • Mentor other RCLs on QRE process and consult leadership on escalated risks. • Serve as SME for QRE as assigned by LM. Serve as a senior consultant on complex consultancy requests and SOP deviations. • Provide strategic, real-time advice to project teams and leadership to ensure first-time quality and resolve high-impact challenges. • Lead investigations into project-level SOP deviations (across projects and accounts), collaborating with SMEs to recommend solutions. • Partner with project teams to sustain an audit/inspection-ready state, providing advanced oversight of storyboards and documentation practices. • Assist with audit and inspection preparations, including prioritizing tasks and reviewing critical documents. • Coach teams on maintaining audit/inspection readiness as a proactive, ongoing priority. • Proactively identify gaps in documentation encouraging project teams to document via project-level story boards where applicable. • Provide senior-level support during audits/inspections, may be required to host audit/inspection and manage high-stakes engagements with confidence and expertise. • Serve as the Quality Representative for Quality Event (QE) – Quality Issues and Audit/Inspection Findings. • Triage quality issues in electronic quality management system (eQMS) setting standards for accuracy and consistency. • Support in the initial assessment of Serious Breach of GCP and coordinate swift and effective containment strategies with the QE team. • Drive Root Cause Analysis (RCA) efforts with established methodologies, ensuring the development and execution of impactful Corrective and Preventive Actions (CAPAs). • Assess and enhance CAPA effectiveness, providing strategic direction to optimize quality outcome. • Review and refine audit/inspection responses prior to final QA submission ensuring alignment with quality standards. • Mentor other RCLs on audit/inspection excellence as Quality Representative. • Exemplify adherence to company standards, ensuring timely completion of training, timesheets, expense reports, and CV updates per SOPs. • Maintain rigorous compliance with ICH-GCP, company processes, and global regulatory requirements. Ensure seamless continuity of responsibilities during absences, coordinating with leadership for oversight. • Mentor other RCLs and serve as an integration partner to facilitate induction into the CDRCM team. • Build and maintain strategic relationships with internal and external stakeholders, including senior client representatives and third-party vendors, to align risk and compliance priorities.

Job Requirements

  • 8-12 years’ experience in clinical research
  • Demonstrated experience in Quality or Risk Management activities
  • Expertise in root cause methodologies and CAPA development
  • Proven leadership in mentoring teams and managing complex, multi-project accounts
  • Comprehensive mastery of ICH-GCP principles and their strategic application
  • Fluency in written and oral English; additional languages an asset
  • Bachelor’s Degree required preferably in life sciences or health-related discipline or equivalent experience.
  • Advanced degree (master’s degree) in a science, technology or industry-related discipline strongly preferred.

Benefits

  • Health insurance
  • Paid time off
  • Flexible working arrangements
  • Professional development opportunities

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