Manager, Clinical Risk and Analytics

Alnylam Pharmaceuticals

14d

About The Position

Overview
The Manager, Clinical Risk & Analytics (CR&A) reports into the CR&A function and is responsible for cross-functional risk management and central monitoring activities for their assigned clinical trials in accordance with ICH GCP E6 requirements.

Requirements

• Proven experience in a clinical research environment.
• College degree, preferably in a scientific, analytical, or technical discipline
• Minimum of 5 years’ experience in the pharmaceutical or CRO industry
• Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program develop.
• Knowledge of Good Clinical Practice/ICH E6 (R2+), ICH E8 R1 Guidelines and/or other applicable regulatory requirements.
• Experience and understanding of Risk Based Monitoring and Site Profiling Tools preferred.
• Familiarity and good understanding and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry
• Good understanding and knowledge of risk management concepts and principles
• High degree of accuracy and attention to detail
• Strong critical thinking and analytical skills, and Aptitude for data analytics, mathematical and statistical concepts is a plus.
• Experience and good 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.
• Project management capabilities
• Excellent English oral and written communication skills

Responsibilities

• Lead study teams in the identification and management of Critical to Quality’ (CtQs) factors, safety, and data integrity risks, operational and other protocol execution risks at study start and throughout study.
• Lead 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.
• Lead definition and selection of Key Risk Indicators (KRIs), and Quality Tolerance Limit (QTL) parameters and other applicable assessments and visualizations for their assigned trials.
• Lead delivery of timely and high-quality RBQM system analytic summaries reports and communicate findings to the cross-functional study team and CRO.
• Work with study team to define the risk mitigations and contingencies from centralized monitoring signals and findings.
• Perform QC and/or validation of study setup in RBQM system vs RBQM Plan and system specifications,
• Collaborate with assigned analyst and programmer to implement and refine study-specific KRIs and QTLs in the RBQM system.
• Ensure inspection readiness for risk management and centralized monitoring scope of activities on the assigned studies.
• Lead the study team through execution of Protocol Risk Assessment (PRA)
• Performs the execution and review of the centralized monitoring assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks in the trial, as needed
• Lead and coordinate with S&MH lead in the definition of site profile oversight tool(s) specifications in alignment with planned RBQM system analytics and outputs, as needed
• Escalates serious risk or issues identified by the CR&A team assigned to the trial to the cross-functional study team, site and monitoring health (S&MH) team, and/or management and Quality, as needed.
• Coordinate and lead end of trial summarization of risk management activities, including QTL and other finding summaries, in preparation for inclusion to Clinical Study Report, as needed
• Participates in continuous improvement and development activities in CR&A and may lead activities as required.

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees