Sr. Manager, Clinical Risk and Analytics

The Senior Manager, Clinical Risk & Analytics (CRA) reports into the DSSE 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. He/she will maintain the Risk Management and Centralized Monitoring system as needed and provides risk management and mitigation guidance to study teams ensuring consistency within and across programs. The Senior Manager, CRA will lead risk management compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements as well as ensuring patient safety and data integrity. Additionally, he/she may act as line manager in CRA team

Summary of Key Responsibilities

The Senior Manager, Clinical Risk & Analytics (CRA) will;

* Line Manage, Train and Mentor CRA staff as required

* Train and mentor Clinical Development staff in risk and issues management, as needed

* 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 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 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 is produced and maintained during the study including study-specific validation

* Work with study team and site and monitoring health (SMH) team to define the most appropriate risk mitigations and contingencies from centralized 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 summarization 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) in system as required * Ensure inspection readiness for clinical risk management and centralized 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

Qualifications

* At least 7 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

* Line Management experience preferred

* Strong understanding of the drug development process and clinical trial execution

* 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 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 visualization technologies * Strong critical thinking and analytical skills, and Aptitude for data analytics, mathematical and statistical concepts is a plus

* High degree of accuracy and attention to detail

* 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.

* Excellent project management capabilities

* Excellent English oral and written communication skills

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.