Clinical Development Risk & Compliance Lead

Hybrid Role (2 days in office, 3 remote)

The Clinical Development Risk and Compliance Management (CDRCM) Department provides expertise in risk and compliance Management at Project and Account level, working with Clinical Development Operations and Leadership and Sponsors to optimize clinical trial delivery safeguarding participant safety, data integrity and regulatory compliance.

Leads in Proactive Risk Management through close collaboration with cross functional leads in identification of Critical to Quality (CTQ) factors; supporting responsible risk owners in developing mitigating actions; analyzing key risk indicators and data trends into actionable insights.

Key Accountabilities

The Risk and Compliance Lead (RCL) is expected to perform the following activities under close supervision from Line Manager (LM).

Lead the risk management process for assigned projects using designated tools.

• Collaborate with operational teams, functional leads and SMEs to identify, categorize, score and develop risk mitigations.
• Evaluate the effectiveness of mitigations in collaboration with functional leads
• Promote the documentation of lessons learned to enhance future performance.
  
  

Analyze key risk indicators and investigate risk signals through Quality Risk Evaluations (QRE), leveraging dashboards, metrics and predictive tools

• Navigate dashboards to detect risk signals and perform associated Quality Risk Evaluations (QREs)
• Communicate identified risks to the project team, providing QRE data and supporting evidence
• Facilitate root cause identification and assist in crafting effective mitigation plans.
• Assess the success of mitigation strategies
  
  

Provide risk and compliance advice for assigned projects, consultancy requests and SOP deviations enquiries based on ICH-GCP, Parexel processes, regulatory requirements, and applicable country standards, with input from SME.

• Provide real-time guidance to project teams to ensure first-time quality delivery
• Review and investigate possible project-level SOP deviations as requested by project teams
  
  

Partner with project teams to maintain an audit-ready state, including oversight of story boards. Assist with audit preparations, including prioritizing tasks and reviewing critical documents.

• Provide guidance on maintaining audit-ready documentation and review of storyboards, as appropriate, for assigned projects as part of audit preparation
• Provide on-site or remote support during audits as needed
  
  

Serve as the Quality Representative for Quality Event (QE) – Quality Issues and Audit/Inspection Findings

• Triage QE within the electronic quality management system (eQMS)
• Support QE owner in conduct of Root Cause Analysis (RCA) Meeting, according to RCA methodologies
• Drive the development of robust corrective and preventive actions (CAPA) and support their effectiveness evaluation with the QE team and action owners
• For QE from Sponsor Audits or Internal Audits, review audit responses prior to final QA review, under supervision of the LM
  
  

Adhere to company standards

• Adhere to company standards, including completing required training, timesheets, expense reports, and CV updates per SOPs
• Ensure compliance with ICH-GCP, Parexel processes, and other applicable requirements.
• Arrange backup coverage during absences and coordinate with the LM to ensure adequate oversight of responsibilities
  
  

Customer Interactions and Relationship Management

• Serve as the primary point-of-contact for client quality representatives on assigned projects, managing relationships, under close supervision from the LM
  
  

Skills

• Good interpersonal, verbal and written communication skills including active listening, group facilitation, influencing without authority and providing appropriate feedback.
• Communicate effectively to build professional and collaborative relationships with internal teams and sponsors.
• Developing proficiency in identifying, extracting and assimilating data to pinpoint risks, trends and aggregated issues.
• Emerging analytical skills with a focus on identifying issues, investigating root causes, exploring alternatives and evaluating action effectiveness.
• Adaptability to dynamic environments, quick-thinking, and capable of managing ambiguity while applying routine knowledge to new tasks.
• Able to plan, organize, and prioritize workload with LM guidance, keeping the patient and Sponsor needs at the forefront.
• Risk and compliance oriented with meticulous attention to detail, initiative, and accountability for deliverables.
• Growing ability to navigate matrix environments while valuing teamwork.
• Willingness to travel 10% -15%
  
  

Knowledge And Experience

• 3-5 years’ experience in clinical research.
• Experience in Risk and Compliance Management preferred
• Solid understanding of ICH-GCP principles
• Proficiency in written and oral English
  
  

Education

• Bachelor’s Degree or equivalent relevant experience required; preference for life-sciences or health-related disciplines.