Clinical Risk Manager - South Africa (Home-Based) - FSP at PAREXEL

About this Role

• Parexel is currently seeking a Risk Manager to join us in South Africa, dedicated to a single sponsor.
• This role will be responsible for facilitating Risk-Based Quality Management (RBQM) conduct on assigned trials, by leveraging knowledge of relevant regulatory requirements and sponsor processes
• It will provide training and support to Clinical Trial Working Groups (CTWGs) on all aspects of risk identification, evaluation, acceptance, control and communication, from study concept to close-out on assigned Phase I – IV trials (in house or outsourced).
• Working as a Risk Manager at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
• Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Conduct all activities of ‘Risk Manager’ for assigned clinical trials, per sponsor RBQM process.
• Provide training and guidance to CTWGs on risk process.
• At the time of Study Concept Document development, facilitate the identification of critical data and processes and records these within the risk tool (file or RACT technology solution).
• Sets up trial-specific RACT.
• Facilitate trial risk assessment by cross-functional CTWG for assigned trials, advising on risk identification, evaluation, acceptance, control, review and communication as appropriate throughout the conduct of the trial.
• Collaborate with appropriate trial contributors in establishment of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for critical risks as well as KRIs and thresholds for non-critical risks, advising on approach and best practice.
• Approve initial risk assessment version, substantial updates and final version.
• As applicable, 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, Electronic Data Capture programmer and Global Monitoring.
• Contributes to development of data review specifications, and specified data reviews.
• As applicable, contributes to and oversees vendor/CRO risk management activities as defined in the Trial Oversight Plan, reporting performance/concerns to AD, RBQM.
• Facilitate review of the risk tool at the frequency and per triggers defined in the Trial Oversight Plan.
• Where a critical risk is realized (QTL breached) contributes to root cause analysis, action plan and ensures contemporaneous record of the QTL breach, remedial actions and outcomes is documented in the risk tool.
• Contribute to maintenance of risk process, templates (including RAMP/RACT), guidance and tools.
• Contribute to Key Risk Indicator (KRI) library, Quality Tolerance Limit (QTL) library/approach.
• Develop expertise in RBQM technology solutions and tools; advises and supports CTWG members with their use.
• Support and promote risk process compliance (including periodic risk review) for assigned trials, providing regular updates and issue escalation to AD, RBQM.
• May coordinate periodic or ad hoc updates per trial or across program(s)/portfolio as required and presents/interprets for key stakeholders.
• Attend RBQM Cross-Functional Forums, as needed
• Champion consistency and knowledge management (Lessons Learned)​.
• Maintains continuous process improvement approach​.
• Support inspection readiness.

Here are a few requirements specific to this advertised role.

• 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.