About this Role<\/p>\n
\tParexel is currently seeking a Risk Manager to join us in South Africa, dedicated to a single sponsor.
\n\tThis 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
\n\tIt 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 \u2013 IV trials (in house or outsourced).
\n\tWorking 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.
\n\tExpect exciting professional challenges in inspiring studies, but with time for your outside life.<\/p>\n
Responsibilities<\/p>\n
\tConduct all activities of \u2018Risk Manager\u2019 for assigned clinical trials, per sponsor RBQM process.
\n\tProvide training and guidance to CTWGs on risk process.
\n\tAt 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).
\n\tSets up trial-specific RACT.
\n\tFacilitate 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.
\n\tCollaborate 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.
\n\tApprove initial risk assessment version, substantial updates and final version.
\n\tAs applicable, liaises with vendor\/CRO as early as possible to ensure cross-functional sponsor input into vendor\/CRO risk assessment.
\n\tCoordinate establishment of trial risk-based monitoring strategy in conjunction with CTWG, Electronic Data Capture programmer and Global Monitoring.
\n\tContributes to development of data review specifications, and specified data reviews.
\n\tAs applicable, contributes to and oversees vendor\/CRO risk management activities as defined in the Trial Oversight Plan, reporting performance\/concerns to AD, RBQM.
\n\tFacilitate review of the risk tool at the frequency and per triggers defined in the Trial Oversight Plan.
\n\tWhere 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.
\n\tContribute to maintenance of risk process, templates (including RAMP\/RACT), guidance and tools.
\n\tContribute to Key Risk Indicator (KRI) library, Quality Tolerance Limit (QTL) library\/approach.
\n\tDevelop expertise in RBQM technology solutions and tools; advises and supports CTWG members with their use.
\n\tSupport and promote risk process compliance (including periodic risk review) for assigned trials, providing regular updates and issue escalation to AD, RBQM.
\n\tMay coordinate periodic or ad hoc updates per trial or across program(s)\/portfolio as required and presents\/interprets for key stakeholders.
\n\tAttend RBQM Cross-Functional Forums, as needed
\n\tChampion consistency and knowledge management\u00a0(Lessons Learned)\u200b.
\n\tMaintains continuous process improvement approach\u200b.
\n\tSupport inspection readiness.<\/p>\n
Here are a few requirements specific to this advertised role.<\/p>\n
\tBachelor\u2019s degree or equivalent required. Master’s or health data sciences degree preferred.
\n\tOperational experience in clinical trial conduct (within trial management, monitoring, data management or related field)
\n\tBroad understanding of clinical trial operations and ability to work collaboratively across functional areas.
\n\tKnowledge of RBQM from a regulatory and best-practice perspective.
\n\tExperience of conducting\/facilitating clinical trial risk assessment and management.
\n\tDemonstrated capabilities in root cause analysis and effective issue resolution.
\n\tStrong analytical and data interpretation skills.
\n\tUnderstanding of statistical analysis techniques, visualizations and tools is helpful but not required.
\n\tAbility to communicate clearly on complex topics – to train, inform, influence and convince.
\n\tFlexible and adaptable to a fast-changing environment.
\n\tAble to carry out responsibilities with minimal supervision.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( https:\/\/www.parexel.com\/ ) or<\/p>\n
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