Clinical Risk Manager – South Africa
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇿🇦 South Africa
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
risk managementclinical trial conductdata managementroot cause analysisstatistical analysisdata interpretationrisk assessmentrisk-based monitoringdata review specificationsKey Risk Indicators
Soft skills
collaborationcommunicationanalytical skillsflexibilityadaptabilityissue resolutiontraininginfluenceconvincingminimal supervision
Certifications
Bachelor's degreeMaster's degree in health data sciences