Overview

The Senior Manager, Clinical Risk & Analytics will report into the DSSE CDM CRA+ function and is responsible for coordinating cross-functional risk management and central monitoring activities, assessments and analytics for their assigned clinical trials in accordance with ICH GCP E6 requirements.

You will maintain the Risk Management and Centralised Monitoring system as needed and provide risk management and mitigation guidance to study teams ensuring consistency within and across programs.

The Senior Manager, Clinical Risk & Analytics will also be tasked with leading risk management compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements alongside ensuring patient safety and data integrity. In additional, line management responsibility of the Clinical Risk & Analytics team, may also form part of this role, depending upon candidate experience.

Primary Responsibilities

• Lead study teams in the identification and management of protocol, critical data and process, ‘Critical to Quality’ elements, safety and data integrity, and other protocol execution risks
• Coordinate and lead the execution of Protocol Risk Assessment (PRA)
• Lead the development of the Risk Management and Action Plan (Risk MAP)
• Perform the set up and maintenance of the Risk-Based Quality Management (RBQM) system based on study teams requirements, data sources and structure
• Perform peer reviews, QC and or Validation of study setup in RBQM system vs RBQM Plan and system specifications, as required
• Lead definition, selection and implementation of Key Risk Indicators (KRIs), and Quality Tolerance Limit parameters (QTLs) and other applicable assessments and dashboards for each study in the RBQM system, ensuring consistency with applicable standards
• Work collaboratively with assigned Programmer to implement and refine study-specific KRIs and QTLs in the RBQM system
• Coordinate and perform, as required, the execution and review of the study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks
• Deliver timely and high-quality risk-based monitoring analytics and supports CRM in communication to the cross-functional study team and CRO (both written report and oral presentation) to identify issue resolution as required
• Lead risk reviews sessions with study teams throughout the study
• Ensure appropriate status and process documentation, including study-specific validation is produced and maintained
• Work with study team to define the most appropriate risk mitigations and contingencies from centralised monitoring signals and findings
• Communicate and/or escalate serious risks and issues to the cross-functional study team and/or management and Quality, as needed
• Coordinate and lead end of trial summarisation of risk management activities, including QTL and other issue findings summaries, in preparation for inclusion to clinical study report.
• Maintain libraries (Risks, KRIs, QTLs, etc) as required
• Ensure inspection readiness for clinical risk management and centralised monitoring activities on the assigned studies
• Champion RBQM within the company and participates in continuous improvement and development of risk management processes and system as needed
• Train and mentor Clinical Development and CR&A staff in risk and issues management, as required

Essential Skills & Experience

• Extensive experience in a pharmaceutical / biologics / biotechnology company
• Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program develop
• Thorough knowledge of Good Clinical Practice/ICH E6 Guidelines and/or other applicable regulatory requirements for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management
• A strong understanding of clinical trials risk management concepts and principles in the Pharma or CRO industry
• Excellent English oral and written communication skills
• Excellent project management capabilities
• Experience with data analytics and data visualisation technologies
• Strong critical thinking and analytical skills, and aptitude for data analytics, mathematical and statistical concepts is a plus
• Experience and understanding of clinical trial data from various sources (e.g. Clinical devices, SDTM, RAVE, IRT, etc.)
• High degree of accuracy and attention to detail
• Ability to work collaboratively in a team environment whilst managing changing priorities to achieve goals/targets
• Ability to build, develop, and maintain good working relationships with internal and external cross-functional customer groups

Desirable Skills and Experience

• Strong critical thinking and analytical skills, and aptitude for data analytics, mathematical and statistical concepts is a plus
• People management experience is preferred but not essential
  

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.