Associate Director, Clinical Risk and AnalyticsAlnylam Pharmaceuticals • Maidenhead, England, United Kingdom
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Associate Director, Clinical Risk and Analytics
Alnylam Pharmaceuticals
- Maidenhead, England, United Kingdom
- Maidenhead, England, United Kingdom
Über
Associate Director, Clinical Risk and Analytics
role at
Alnylam Pharmaceuticals .
Overview The Associate Director, Clinical Risk & Analytics (CR&A) is responsible for coordinating and overseeing cross‑functional risk management and central monitoring activities for their direct reports and assigned Alnylam clinical trials in accordance with ICH GCP E6 requirements. The associate director has comprehensive knowledge of study management, data management, site monitoring, and/or clinical science processes that can be applied to identify issues/risks and lead clinical study teams and CR&A team members to apply effective and efficient mitigations and monitoring strategies.
Responsibilities
Lead, develop, coach, and manage members of the global Clinical Risk & Analytics (CR&A) team.
Responsible for managing, maintaining and updating their assigned portion of the RBQM framework (e.g., training, processes, documentation, system(s)) for CR&A.
Assist in creating and driving the vision and operating model of RBQM+ in Clinical Development.
Act as RBQM Lead on assigned trials(s), including the development of the Risk Management and Action Plan (Risk MAP), RBQM Plan, Integrated Data Quality Plan (IDQP), and Targeted SDV and SDR planning on assigned trials.
Along with the Director of CR&A develop and maintain appropriate metrics, dashboards and communication tools regarding RBQM.
Deliver and ensure delivery of timely and high‑quality RBQM system analytic summary reports and communicate findings to cross‑functional study teams and CRO.
Ensure inspection readiness for clinical risk management and centralized monitoring activities on their team and their own assigned studies.
Provide insight to Alnylam and CRO study team on best practices of risk management, vendor oversight, and Centralized Monitoring.
Train and mentor CR&A and/or Clinical Development team in risk management and centralized monitoring as needed.
Guide teams on inspection readiness and study risk preparation in the event of a regulatory authority audit in partnership with QA. Interface with regulatory inspectors, as needed.
Coordinate, lead and participate in continuous improvement activities in CR&A and beyond, as required.
Demonstrate clear alignment with Alnylam Core Values including Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.
Requirements
Proven experience in a clinical research environment.
Bachelor's Degree required; advanced degree (MS, MA, MBA, PharmD) preferred.
Previous experience in study management, site monitoring, data management, risk management and/or centralized monitoring preferred.
Proven experience effectively leading and managing teams and globally based staff.
Solid direct risk management and process development experience gained with a CRO or pharmaceutical company working on multinational clinical studies.
Experience in all study phases of clinical research (Phase I-IV) preferred.
Experience building, developing and maintaining good working relationships with internal and external customer groups.
Strong aptitude for data analytics, mathematical and statistical concepts.
Experience and understanding of Risk Based Monitoring and Site Profiling Tools preferred.
Experience with and good understanding of clinical data.
Previous regulatory inspection experience preferred.
Comprehensive and current regulatory knowledge, including Good Clinical Practice/ICH E6 Guidelines and/or other applicable regulatory requirements.
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 while managing changing priorities to achieve goals/targets.
Excellent leadership and organizational skills and ability to deal with competing priorities.
Excellent project management capabilities.
Effective communication skills (written, verbal and presentation).
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. #J-18808-Ljbffr
Sprachkenntnisse
- English
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