Clinical Risk Analyst

Alnylam Pharmaceuticals

11d

About The Position

The Clinical Risk Analyst - Site Profile (CRA-SP), Clinical Risk & Analytics (CR&A) reports into the CR&A function and is responsible for the delivery of timely and high-quality Site Profile assessments and analytics for clinical trials in accordance with ICH GCP E6 requirement.

Requirements

Proven experience in a clinical research environment.
At least 3 years’ 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.
Familiarity and good understanding and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry
Experience in Site Profiling Tools set up and management preferred.
Experience with data analytics and data visualization technologies
SAS, R-Language or SQL programing experience preferred.
Strong critical thinking and analytical skills and aptitude for data analytics including mathematical and statistical concepts.
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 English oral and written communication skills

Responsibilities

Supports cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification, and evaluation into Risk MAP
Support RBQM Leads in selection and implementation of Key Risk Indicators (KRIs), and other applicable assessments outcomes from the RBQM system into a Site Profile system, ensuring consistency with applicable standards.
Support Site & Monitoring Health (S&MH) in the use and management of the Site Profiling Tool.
Set up Site profile tool in support of site risk leveling taking information from RBQM system, and additional analytics, as well as KRIs, QTLs, data quality assessments, and other visualizations.
Perform the maintenance of the Site Profile tool based and/or RBQM System in line with RBQM Plan requirements, data sources, and structure.
Perform peer reviews, QC and or validation of study setup of the Site profile tool and/or RBQM system.
Collaborate with assigned programmer to implement study-specific KRIs, QTLs, visualization, and other analytics from the RBQM system into the Site profiling tool.
Performs the execution study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data in RBQM system and Site profiling tool.
Deliver timely and high-quality analytics and supports RBQM leads and S&MH leads in communication to the cross-functional study team to identify resolution as required.
Ensure appropriate status and process documentation is produced and maintained during the study.
Ensure inspection readiness for clinical risk management and centralized monitoring activities.
Communicates and/or escalates serious risks and issues to the RBQM Lead and S&MH lead, study team and/or management and Quality, as needed.
Supports RBQM Lead in conducting end of trial summarization of risk management activities 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.

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