Parexel Clinical Development Risk & Compliance Lead Recruitment 2026: Apply Online for Various Vacancies

Detailed Job Overview

Parexel is currently seeking a highly motivated and analytical professional to join our Clinical Development Risk and Compliance Management (CDRCM) Department as a Clinical Development Risk & Compliance Lead. This department provides critical expertise in risk and compliance management at both the project and account levels, working closely with Clinical Development Operations, leadership, and sponsors to optimize clinical trial delivery. The primary objective of this role is to safeguard participant safety, ensure data integrity, and maintain strict regulatory compliance across all assigned clinical trials. Operating in a hybrid work environment (2 days in office, 3 remote) out of Baltimore, Maryland, the successful candidate will drive proactive risk management initiatives and foster a culture of quality first.

Key Responsibilities and Accountabilities

The Risk and Compliance Lead (RCL) will perform a wide array of activities under the supervision of the Line Manager. Key responsibilities include:

• Proactive Risk Management: Lead the risk management process for assigned projects using designated tools. Collaborate with operational teams, functional leads, and subject matter experts (SMEs) to identify, categorize, score, and develop robust risk mitigations.
• Data Analysis and Insights: Analyze key risk indicators and investigate risk signals through Quality Risk Evaluations (QRE), leveraging advanced dashboards, metrics, and predictive tools. Navigate dashboards to detect risk signals and perform associated QREs.
• Root Cause Analysis (RCA): Facilitate root cause identification and assist in crafting effective mitigation plans. Assess the success of mitigation strategies and promote the documentation of lessons learned to enhance future performance.
• Compliance Advisory: Provide real-time risk and compliance advice for assigned projects, consultancy requests, and SOP deviation enquiries based on ICH-GCP, Parexel processes, regulatory requirements, and applicable country standards.
• Audit and Inspection Readiness: Partner with project teams to maintain an audit-ready state, including oversight of storyboards. Assist with audit preparations, prioritize tasks, review critical documents, and provide on-site or remote support during audits as needed.
• Quality Event Management: Serve as the Quality Representative for Quality Events (QE) including Quality Issues and Audit/Inspection Findings. Triage QEs within the electronic quality management system (eQMS), support QE owners in conducting RCA meetings, and drive the development of robust corrective and preventive actions (CAPA).

Required Qualifications and Experience

To be successful in this role, candidates must meet the following criteria:

• Education: A Bachelor’s Degree or equivalent relevant experience is required. A strong preference is given to candidates with degrees in life-sciences, healthcare, or related disciplines.
• Experience: 3 to 5 years of hands-on experience in clinical research is required. Prior experience in Risk and Compliance Management is highly preferred.
• Regulatory Knowledge: A solid and practical understanding of ICH-GCP principles, regulatory requirements, and country-specific standards is essential.
• Language Skills: Professional proficiency in written and oral English is required to communicate effectively with global teams and sponsors.

Essential Skills for Success

Candidates must demonstrate a robust set of professional and interpersonal skills, including:

• Communication: Excellent interpersonal, verbal, and written communication skills, including active listening, group facilitation, and the ability to influence without authority.
• Analytical Thinking: Emerging analytical skills with a focus on identifying complex issues, investigating root causes, exploring alternatives, and evaluating action effectiveness.
• Adaptability: Ability to thrive in dynamic, fast-paced environments, think quickly on your feet, and manage ambiguity while applying routine knowledge to new tasks.
• Attention to Detail: A strong risk and compliance orientation with meticulous attention to detail, initiative, and accountability for deliverables.

Parexel is a leading global clinical research organization (CRO) contracted by pharmaceutical, biological, and medical device manufacturers to manage clinical research studies and support product development. With a compassionate and results-driven work culture, Parexel prioritizes patient care, employee growth, and global inclusion.