Senior Central Risk Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in Poland.

📋 Description

• Offer expert advice and subject matter knowledge for the creation of project monitoring strategies.

• Advise project teams on updates to monitoring strategies in response to risks.

• Collaborate with cross-functional leads to comprehend complex indications and risks while identifying mitigation strategies.

• Provide direction to ensure uniformity across programs, therapeutic areas, and sponsors.

• Prepare initial risk assessments and assist in finalizing the Risk Assessment Categorization Tool (RACT).

• Ensure that identified risks are recorded in the appropriate tracking system.

• Support ongoing cross-functional evaluations of project risks.

• Provide recommendations on functional plans to mitigate recognized risks.

• Evaluate tools for remote data review and centralized statistical monitoring.

• Identify potential risks to data quality and integrity.

• Facilitate the review of findings with internal cross-functional teams and sponsors.

• Collaborate to establish Quality Tolerance Limits.

• Create and present initial and ongoing training on risk assessment, centralized monitoring, and risk-based monitoring strategies.

• Coach and mentor peers in functional execution, project risk assessment, and action implementation.

• Work with functional areas to ensure adherence to protocols, ICH/GCP, GPP, and local regulations.

• Maintain readiness for inspections related to risk assessment and centralized monitoring scope.

• Understand the study's scope of work, budget, and protocol details.

• Raise concerns about at-risk deliverables, out-of-scope activities, and requests to the Project Manager.

• Engage in business development activities, including insights on monitoring strategies and budget input, meeting definitions, and proposal development.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• A Master's degree or health data sciences degree is preferred.

• Proficient in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other relevant regulatory requirements.

• Expertise in Risk-Based Monitoring Strategies processes and tools is preferred.

• In-depth knowledge of Integrated Quality Risk Management (IQRM) theories.

• Strong computer skills and an aptitude for adopting new technologies.

• Proficient in MS Excel, including sorting, filtering, calculating, and pivoting functions.

• Expertise in analytical data visualization tools.

• Familiarity with statistical analysis techniques, visualizations, and tools such as Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, and Box and Whiskers.

• Understanding of Lean Six Sigma and RACT tools.

• Strong analytical abilities coupled with a solid grasp of statistical concepts.

• Well-developed therapeutic knowledge.

• Exceptional verbal and written communication abilities.

• Strong negotiation, organizational, and problem-solving skills.

• Demonstrated leadership, tactical, and strategic thinking capabilities.

• Aptitude to foresee and address critical issues while proactively devising contingency plans.

• Knowledge of financial concepts related to forecasting, budgeting, and proposal creation.

• Understanding of workflow processes, roles, and responsibilities across various functional areas.

• Ability to comprehend, explain, and communicate project concepts, translating them into detailed plans.

• Capability to teach, train, and mentor employees at all levels.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a comprehensive rewards program.

• An inclusive culture.

• Access to extensive resources including emerging technologies, data, science, and knowledge sharing.

• Opportunities for collaboration within specialized therapeutic or functional teams.

• Diverse career paths and employment opportunities.