Central Risk Manager – Risk Based Central Monitoring

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

📋 Description

• Provide guidance on the formulation and revisions of project monitoring strategies in relation to risks.

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

• Prepare initial risk assessments and assist in the finalization of the Risk Assessment and Communication Tool (RACT).

• Ensure that identified risks are logged into the appropriate tracking system and facilitate ongoing cross-functional reviews.

• Offer advice on functional plans to alleviate identified risks.

• Evaluate tools for remote data review and centralized statistical monitoring, while pinpointing data quality and integrity risks.

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

• Collaborate to establish Quality Tolerance Limits.

• Create and deliver initial and continuous training on risk assessment, centralized monitoring, and risk-based monitoring strategies.

• Mentor and coach colleagues on functional delivery, project risk assessment, and action implementation.

• Work across functions to ensure compliance with protocols, ICH/GCP guidelines, Good Publication Practice (GPP), and national regulations.

• Maintain inspection readiness for risk assessments and centralized monitoring processes.

• Grasp the scope of work, budget, and protocol for assigned studies.

• Raise concerns regarding at-risk deliverables and activities outside of the specified scope to the Project Manager.

• Engage in business development, monitoring strategy formulation, budgeting discussions, meetings, and proposal crafting.

⛳️ Requirements

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

• Preferred: Master’s degree or a degree in health data sciences.

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

• Preferred: Expertise in Risk-Based Monitoring Strategies processes and tools.

• Proficient in Integrated Quality Risk Management (IQRM) principles.

• Strong computer proficiency and an openness to new technologies.

• Advanced skills in MS Excel (including sorting, filtering, calculating, and pivoting).

• 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.

• Knowledge of Lean Six Sigma and RACT tools.

• Strong analytical abilities and a solid understanding of statistical concepts.

• Well-established therapeutic expertise.

• Exceptional verbal and written communication capabilities.

• Strong skills in negotiation, organization, problem-solving, leadership, tactical, and strategic thinking.

• Ability to proactively anticipate and address critical issues and develop contingency plans.

• Understanding of financial concepts related to forecasting, budgeting, and proposal generation.

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

• Capability to grasp, articulate, and communicate project concepts while creating detailed plans.

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

• Above-average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.

• Excellent written and verbal communication and presentation skills.

• Willingness to travel less than 30% of the time.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• A comprehensive total rewards program.

• An inclusive workplace culture.