Compliance

• 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.

Clinical Development Risk & Compliance Manager

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication for site review and management of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points.
• Participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans.

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Clinical Development Risk & Compliance Manager

Regulatory and Site Start-Up Specialist