Global Monitoring and Investigations Manager
Clinigen · Shah Alam
The Global Monitoring and Investigations Manager is a key delivery role within Clinigen’s Ethics & Compliance function, responsible for designing and running practical monitoring activity, maintaining the supporting trackers/tools, and managing investigation casework from intake through to closure and remediation tracking.
The role helps the organisation anticipate and manage compliance and ethics risks through structured monitoring, clear documentation, strong stakeholder engagement, and professional handling of concerns raised via Speak Up or other channels.
The role also contributes to building Clinigen’s compliance maturity by turning monitoring and investigations into actionable insight — trends, root causes, control gaps and improvements — and supporting consistent reporting to senior stakeholders
Key Responsibilities:
1) Global Compliance Monitoring (Planning & Execution)
- Support the development and delivery of Clinigen’s annual risk‑based compliance monitoring plan, using risk inputs (e.g., ABAC, third‑party risk, conflicts, gifts/hospitality, audit themes) to prioritise activity.
- Execute monitoring reviews (transaction testing, thematic reviews, controls verification, documentation checks), ensuring work is evidence‑based, proportionate, and well‑documented.
- Maintain monitoring workpapers, trackers, and outputs so findings are traceable, consistent, and repeatable (i.e., “monitoring infrastructure” at an operational level).
- Coordinate monitoring activity with key functions (Finance, QA, HR, Legal and operational teams) to avoid duplication and ensure clarity of ownership and remediation.
- Support follow‑up and verification of remediation actions and CAPAs arising from monitoring, audits, or investigations.
2) Investigations & Speak Up Case Management
- Support the intake, triage, tracking and documentation of Speak Up concerns and other ethics/compliance allegations, ensuring confidentiality and appropriate routing.
- Apply consistent investigation methodologies and documentation standards aligned to best practice and internal protocols
- Lead or support investigations (as assigned) including planning, evidence gathering, interviews, analysis, and clear reporting of findings and recommendations.
- Maintain investigation logs, action trackers and closure documentation; monitor remediation actions to completion.
- Work closely with Legal/HR and Data Privacy stakeholders to ensure investigations are conducted appropriately and personal data is handled in a privacy‑compliant manner.
- Ensure investigations are conducted in line with whistleblower protection requirements, non‑retaliation principles, and Clinigen’s Speak Up commitments
- Escalate matters appropriately where allegations involve senior management, regulatory risk, or potential legal exposure, ensuring independence and consistency of approach
3) Analytics, Reporting & Insight
- Produce monitoring and investigations reporting that highlights outcomes, trends and actions — with practical insight for senior stakeholders.
- Support development and maintenance of dashboards/metrics (e.g., monitoring activity, issue types, closure times, repeat themes, remediation health).
- Ensure insights from monitoring/investigations feed back into improvements to policies, training, controls, and compliance communications.
4) Stakeholder Engagement & Programme Enablement
- Build strong working relationships with key internal stakeholders to enable timely monitoring, investigations and remediation. [Senior Dir...5_LD (004) | Word], [Ethics and...C revised) | Word]
- Support guidance, training or briefing materials that help teams understand expectations and evidence requirements (including audit‑readiness alignment). [Ethics and...C revised) | Word]
- Contribute to improvements in monitoring methodologies and tools, adopting best‑practice approaches that are realistic for Clinigen’s operating environment.
Additional Duties:
The above list is not exhaustive. Duties may evolve based on business needs, and the post‑holder is expected to work flexibly to support the wider Ethics & Compliance programme. The post‑holder is also expected to act as a trusted business partner — building relationships, providing clear and practical guidance, and helping colleagues make sound, risk‑aware decisions aligned to Clinigen’s values
The role also contributes to strengthening Clinigen’s ethical decision‑making culture by supporting the development of tools, guidance, and behaviours that help colleagues navigate ethical dilemmas and embed integrity into daily operations
Requirements
- Experience in compliance monitoring, investigations, audit, risk, legal, HR investigations, or a related assurance discipline.
- Experience producing evidence‑based written outputs (monitoring reports, investigation summaries, metrics, dashboards).
- Experience in a regulated environment (pharma/life sciences, healthcare services, or similarly regulated sectors) is desirable.
- Familiarity with compliance systems/tools and structured case or workflow tracking is desirable.
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