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.