Clinical Risk Manager I

Premier Research Group; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Premier Research Group is seeking a Clinical Risk Manager I to join our Clinical Management team in the United States. You will help biotech, medtech, and pharmaceutical partners translate science into medicines, devices and diagnostics, while contributing to risk-based monitoring and integrated risk management.

The role emphasizes RBQM leadership, risk assessment, QTL development and cross-functional collaboration, with up to 20% travel for sponsor meetings.

Qualifications

• Significant clinical research experience with RBQM, Central Monitoring and Project Management.
• Expertise with ICH-GCP and ICH E6 guidelines and RACT tools preferred.
• Strong analytics, data interpretation and decision-making abilities.

Responsibilities

• Support Bidder, Proposals and Business Development by outlining monitoring strategy based on risk assessment.
• Complete the study RACT for complex/global trials with cross-functional mitigations.
• Evaluate and establish QTL parameters with required functions.
• Ensure the proposed RBM strategy is fit for purpose and risk proportionate.
• Coordinate data reviews via analytics and provide tools for Central Monitor as applicable.
• Author the Integrated Quality Risk Management Plan for assigned studies.
• Serve as SME on Risk Management and RBM for assigned studies.
• Support cross-functional protocol execution risk reviews throughout the project life cycle.
• Assist Kick Off meetings for new awards and opportunities.

Skills

RBQM expertise

KRI & QTLs

ICH-GCP knowledge

RBM tools (RACT)

Analytical skills

English communication

Education

Bachelor in Biological Sciences/Health Sciences

Tools

MS Excel

BI tools

Job description

Premier Research is looking for a Clinical Risk Manager I to join our Clinical Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What you’ll be doing:

• Support Clinical Bidder, Proposals and Business Development by providing the rationale for the overarching monitoring strategy based on initial risk assessment, as needed.

• Upon study award, completes the study RACT for complex and/or global trials, which includes identification of Critical Data and Critical Processes, as well as protocol execution risks and cross functional mitigative strategies for the identified risks, with study team input.

• Evaluates whether Quality Tolerance Limits (QTLs) should be considered, and if so, leads discussion with required functions to establish initial QTL parameters.

• Confirms the proposed custom monitoring strategy is fit for purpose and risk proportionate.

• Ensures the Central Monitor, if in scope, has the required tools to perform aggregated data reviews via analytics, or other methods.

• Creates configuration notes for programmers of Clinical Analytics.

• Authors the Integrated Quality Risk Management Plan (IQRMP) for assigned studies.

• Serves as a Subject Matter Expert (SME) on Risk Management and Risk Based Monitoring (RBM) activities for assigned studies.

• Supports functional leads in completing functional project plans, ensuring relevant mitigations are captured as expected.

• Supports ongoing cross-functional protocol execution risk reviews through the entire project life cycle.

• Supports Kick Off meetings for new awards and opportunities.

• Ensures inspection readiness related to Risk Management and RBM strategy by maintaining accurate and complete documentation.

• Build knowledge of RBQM processes and share learnings within the team.

What we are searching for:

• Bachelors inBiologicalSciences,HealthSciences and/or related disciplines in the health care domain.

• Significant clinical research experience,8+years of related experience to RBQM, Central Monitoring and Project Management. Subject matter expertise on ICH-GCP, ICH E6 (R2+ R3) Guidelines and RACT tools,preferred.

• Subject matter expertise on RBQM, KRI, QTLs,QbD, Centralized Monitoring, Budgeting and Contracts

• Understands the key concepts of RBQM, Key Risk Indicators (KRI), Quality Tolerance Limits (QTLs), Quality by Design (QbD), Clinical, Centralized Monitoring and budget.

• Excellent analytical, computational, judgement and decision-making ability

• Strong fundamental understanding of statistical concepts, statistical analysis techniques and Integrated Quality Risk Management (IQRM) theories

• Lead process improvement initiatives at department/organizational level

• Expertise with MS Excel, Business Intelligence tools and leverages data visualizations for decision making.

• Experience of collaborating with cross-functional global team for solving complexproblem

• Excellent verbal and written communication skillsin English

• Ability to travel up to 20%for sponsormeetings.