The Central Risk Manager I (CRM I) serves as the subject matter expert for protocol execution risk management, risk-based monitoring (RBM) strategy and centralized monitoring within the project team. The CRM is accountable for drafting the initial RBM strategy, working with the cross-functional teams to assess protocol execution risks and adapt the cross-functional RBM strategy.
Provides advice and subject matter expertise for the development of the monitoring strategy required for the project and where required, advises the project team on any updates to the monitoring strategy during the study based on risks.
Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations. Provides guidance to cross-functional leads to ensure consistency within programs, therapeutic areas and/or sponsors.
Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross-functional review of risks throughout the project.
Provides advice on the development of functional plans to ensure identified risks are mitigated.
Assess tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
Facilitates review of findings with the internal cross- functional team and sponsor. Requires support from cross-functional leads on complex risks and mitigations.
With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy.
Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.
Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
Understands the study scope of work, budget and protocol content for their assigned study.
Escalates to the PM any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.
This job excludes CO applicants.
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
Master's degree or health data sciences degree preferred.
Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
Expert in Risk-Based Monitoring Strategies processes and tools preferred.
Expert in Integrated Quality Risk Management (IQRM) theories.
Must demonstrate good computer skills and be able to embrace new technologies.
Mastery of MS Excel (sorting, filtering, calculating, pivoting).
Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers).
Knowledge of statistical analysis techniques, visualizations and tools (Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, Box and Whiskers).
Knowledge of Lean Six Sigma, RACT tools.
Strong analytical skills and well-developed understanding of statistical concepts.
Well-developed therapeutic expertise.
Excellent verbal and written communication skills.
Strong negotiation skills, organizational skills and problem-solving skills.
Demonstrated strong leadership, tactical and strategic thinking skills.
Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas.
Ability to understand, explain and communicate project concepts and put into detailed plans.
Ability to teach, train and mentor employees of all levels to achieve project, departmental, personal and organizational goals.
Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.