Risk Surveillance Lead - Clinical Trial Quality Management

Risk Surveillance Lead Job Description Summary #LI-Hybrid This role is based in our Hyderabad offices with an expectation of 12 days per month onsite. The Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall account-ability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles. Job Description Major Accountabilities: Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP) Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system Conduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issues Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies Supports and participates in internal and external audits and inspection Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach. Identifies and shares lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit Experience: Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience Minimum of 4 years of experience in the pharmaceutical or CRO industry Preferred minimum of 1 years of experience in Risk Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions Knowledge of RBQM IT systems or other data analytic systems Demonstrated ability to analyze data, identify patterns and make recommendations for improvement Demonstrated ability to effectively lead cross functional team meetings Experience forming cross-functional collaborations; strong interpersonal skills Supports a culture of continual improvement and innovation; promotes knowledge sharing Ability to influence without authority Thinks creatively; challenges the status quo Languages: English: fluent written and spoken Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Commitment to Diversity and Inclusion / EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. Skills Desired Budget Management, Clinical Research, Clinical Trial Protocols, Clinical Trials, Coaching, Cross-Functional Teamwork, Data Analysis, Learning Design, Lifesciences (Inactive), Risk Management, Risk Monitoring Experience Level Senior Level