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ICON Strategic Solutions Clinical Risk Manager in Boston, Massachusetts

Overview

Overview:

Coordinate and oversee the execution of risk management for GCPM managed studies, (early, late and observational), globally

Oversee the quality of risk management for studies at a global level

Collaborates with cross functional stakeholders to ensure continuous, timely and quality risk management

Responsibilities

Responsibilities:

• Leading the Clinical Study Team to drive effective decision making for risk management

• Ensuring risk management implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines

• Responsible for CT-RACT completion and updates (by the CST) throughout the lifecycle of the clinical study

• Input to the development of the study protocol and functional plans

• Plan and lead high quality risk management discussions and reviews, including the identification and review of risks, critical data & critical processes

• Guide team on the process, requirements and how to complete the CT-RACT

• Review and ensure holistic quality (e.g. risk grading has sufficient rationale, not responsible to ensure inclusion of the appropriate study risks)

• Review adherence to timelines and requirements

• Responsible for feedback on risks to protocol development

• Support the development of risk mitigation strategies

• Lead reviews of mitigation effectiveness.

• Analyse, summarize and report findings to inform future study design and library of mitigations.

• Track and oversee completion of mitigation actions – progress reports to CST

• Provide advice on the development of functional plans.

• Provide advice and input to functional plan updates - drive RBSE thinking

• Provide advice on linking risks to the standard KRIs, and identify study-specific KRIs

• Provide ongoing feedback for CT-RACT tool enhancements

• Support messaging, training and roll out of tool enhancements

• Extended member of the (G)CST:

• Agenda-driven attendance at Study Team Meetings for topics of CT-RACT, Functional Plan reviews, KRI identification

Qualifications

Preferred Qualifications:

• BS/BA/BSc in the sciences or RN

• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company

• Experience of or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

• Experience as a Risk Manager, preferred

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Posted Date 7 hours ago (11/30/2022 11:29 PM)

ID 2022-96610

Location : Location US-Remote

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