Clinical Development Risk & Compliance Manager

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

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, drawing on deep knowledge of ICH GCP, Parexel processes, regulatory requirements, and applicable country standards

• 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

• 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

Mentorship and Team Support

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

Customer Interactions and Relationship Management

• Build and maintain strategic relationships with internal and external stakeholders, including senior client representatives and third-party vendors, to align risk and compliance priorities.
• When assigned the role of Account Risk and Compliance Lead (ARCL):
  • Lead quality-to-quality meetings as needed
  • Perform account-level risk and issue management
  • Provide account-level quality oversight, serving as a point of escalation and communicating pertinent information to account leadership as necessary
  • Develop or revise quality agreements as required

Champion innovative improvement in identifying gaps, leading initiatives, and influencing organizational strategy

• Drive innovation by proposing and implementing advanced solutions to CDRCM leadership, enhancing departmental efficiency and standards.
• Review and provide feedback on SOPs as assigned.

Skills:

• Outstanding interpersonal, verbal, and written communication skills with proven ability to influence senior stakeholders, lead discussions, and mentor diverse teams.
• Exceptional relationship-building capabilities, fostering trust and collaboration with internal teams, clients and external partners.
• Advanced proficiency in synthesizing complex datasets to identify trends, mitigate risks, and inform strategic decisions.
• Expert analytical skills, excelling in risk identification, root cause analysis, and strategic evaluation of interventions.
• Highly adaptable, with a demonstrated ability to lead through ambiguity, apply critical thinking, and drive change in dynamic environments.
• Masterful in planning, prioritizing, and managing complex workloads independently, with a relentless focus on patient and client outcomes.
• Compliance- and risk-focused, with meticulous attention to detail, ownership of outcomes, and a proactive leadership approach.
• Experienced in navigating and leading within matrix environments, inspiring teamwork and delivering results across functions.
• Willingness to travel 15% - 20%.

Knowledge and Experience:

• 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.

Education:

• 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.