Clinical Risk Analyst

The Analyst, Clinical Risk & Analytics (CRA) reports into the DSSE CRA function and is responsible for the delivery of timely and high-quality Centralized Monitoring activities, assessments and analytics for their assigned clinical trials in accordance with ICH GCP E6 requirement.

Working closely with other CRA team members the Analyst will support the risk assessment and compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements to ensure patient safety and data integrity.

Summary of Key Responsibilities

The Analyst, Clinical Risk & Analytics (CRA) will;

• Support other CRA team members, acting as RBQM Leads, in the identification and management of protocol, critical data and process, 'Critical to Quality' elements, safety and data integrity, and other protocol execution risks
• Supports cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification and evaluation into Risk MAP, as required.
• Support RBQM Leads in 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.
• 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.
• Work collaboratively with assigned Programmer to implement and refine study-specific KRIs and QTLs in the RBQM system
• Performs, 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 supportsRBQM leads in communication to the cross-functional study team and CRO (bothwrittenreport and oralpresentation)to identify issue resolution as required
• Support RBQM Leads during risk reviews sessions with cross-functional study team throughout clinical trials lifecycle
• Ensure appropriate status and process documentation is produced and maintained during the study including study-specific validation
• Communicate and/or escalate serious risks and issues to the cross-functional study team and/or management and Quality, as needed
• Support RBQM Lead in conducting end of trial summarization of risk management activities, including QTL and other issue findings summaries, in preparation for inclusion to clinical study report.
• Ensure inspection readiness for clinical risk management and centralized monitoring activities scope of activities
• Champion RBQM within the company and participates in continuous improvement and development of risk management processes and system as needed

Qualifications

• Proven experience in a clinical research environment.
• At least 3 years experience in a 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

Skills

• Familiarity and good understanding and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry
• Experience with data analytics and data visualisation technologies
• Strong critical thinking and analytical skills and aptitude for data analytics including mathematical and statistical concepts
• Highdegreeofaccuracyand attention todetail
• Experience and understanding of clinical trial data from various sources (e.g. Clinical devices, SDTM, RAVE, IRT, etc)
• 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.
• ExcellentEnglishoral andwrittencommunicationskills

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.