Clinical Risk Manager – South Africa

Yesterday

Apply Now

Receive Emails with Similar Jobs

Parexel

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Conduct all activities of ‘Risk Manager’ for assigned clinical trials, per sponsor RBQM process • Provide training and guidance to CTWGs on risk process • Facilitate the identification of critical data and processes and records these within the risk tool • Sets up trial-specific RACT • Facilitate trial risk assessment by cross-functional CTWG for assigned trials • Collaborate with appropriate trial contributors in establishment of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) • Approve initial risk assessment version, substantial updates and final version • Liaises with vendor/CRO as early as possible to ensure cross-functional sponsor input into vendor/CRO risk assessment • Coordinate establishment of trial risk-based monitoring strategy in conjunction with CTWG • Contributes to development of data review specifications, and specified data reviews • Contributes to and oversees vendor/CRO risk management activities as defined in the Trial Oversight Plan • Facilitate review of the risk tool at the frequency and per triggers defined in the Trial Oversight Plan • Contribute to maintenance of risk process, templates (including RAMP/RACT), guidance and tools • Develop expertise in RBQM technology solutions and tools; advises and supports CTWG members with their use • May coordinate periodic or ad hoc updates per trial or across program(s)/portfolio as required and presents/interprets for key stakeholders.

🎯 Requirements

• Bachelor’s degree or equivalent required • Master's or health data sciences degree preferred • Operational experience in clinical trial conduct (within trial management, monitoring, data management or related field) • Broad understanding of clinical trial operations and ability to work collaboratively across functional areas • Knowledge of RBQM from a regulatory and best-practice perspective • Experience of conducting/facilitating clinical trial risk assessment and management • Demonstrated capabilities in root cause analysis and effective issue resolution • Strong analytical and data interpretation skills • Understanding of statistical analysis techniques, visualizations and tools is helpful but not required • Ability to communicate clearly on complex topics - to train, inform, influence and convince • Flexible and adaptable to a fast-changing environment • Able to carry out responsibilities with minimal supervision.

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities