AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
Job Description
Purpose:The Study Risk Lead is the risk management subject matter expert for study execution and central monitoring in AbbVie's end-to-end RBQM model—a critical pillar required in AbbVie's mission to be a world-class R&D organization. The Study Risk Lead partners with the cross-functional study team and the Central Monitor team. The purpose of the Study Risk Lead is to establish the early detection and intervention framework for study risks, determining what to look for and how to intervene effectively, to enable proactive risk mitigation before the study starts and throughout the study as new risks emerge. The Study Risk Leads function is de-centralized and includes team members from across the globe. Study Risk Leads are responsible for multiple-jurisdiction studies with sites across the globe.
Responsibilities:
- Coach and develop the risk mindset, the discipline of risk management and risk practices/processes within the cross-functional study team—further maturing processes and building organizational capabilities in the pursuit of better quality and outcomes for patients, investigators, the study team and AbbVie as a business, and inspection readiness.
- Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of programs and protocols.
- Work collaboratively in the pursuit of quality with the study team and cross-functional departments.
- Facilitate the Risk Assessment and Mitigation (RAMP) meetings (initial and ongoing).
- Support the cross-functional study team in identifying risks and planning for potential mitigations.
- Prepare Risk Assessments and Mitigation Plans (RAMP) documents as per AbbVie standards.
- Continually review and evolve the Risk Assessments and Mitigation Plans (RAMP) throughout the study to ensure proactive action and responses to anticipated risks as well as newly emerging real-time risks.
- Ensure the output of the RAMP discussions are reflected in applicable study plans so that team is focusing on the most important risks and mitigations.
- Guide the team in identifying the most critical data and processes that need to be controlled to ensure study success.
- Help define Key Risk Indicators (KRIs), both AbbVie standard and study specific, that will best help paint the picture of potential risk in the study.
- Bring rigor, consistency and a common risk-based vocabulary to the defining and documentation of risks to promote shared understanding and appropriate decision making.
- Leverage provided guidelines and standards for documenting the situation, the conditions under which it may occur, the risk level (how the risk is measured, the potential impact should the risk occur, and the likelihood of the risk occurrence).
- Identify inconsistent practices between studies, communicating to the Director to assist with breaking down silos.
- Participate in Health of Study Meetings. Translate the issue / emerging risk—the situation, the significance / implication of the data insight, and what further action is required—breaking down complex concepts into simple language. Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk so that the appropriate follow-up action can be taken.
- Be an RBQM champion across AbbVie, supporting the execution of RBM processes as part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).
Qualifications
- Bachelor's degree in related field, may include life sciences, risk-based discipline.
- Minimum of 5 years of clinically related experience or data trend analysis experience; 1 year is preferable in clinical research monitoring.
- Risk Management Certifications a plus (e.g., Industry Certifications —ASQ Certified Manager of).
- Experience working in an RBQM-framework model or equivalent experience with risk-based principles required.
- Demonstrated current knowledge and understanding or willingness to learn appropriate therapeutic indications, regulations, and ICH/GCP guidelines as they relate to the conduct of clinical trials (study management, data management and regulatory operations).
- TA experience preferred in one of the following areas (Neuroscience, Oncology, Immunology, Eye Care, Medical Aesthetics, Women's Healthcare, GI).
- Embraces the role of an early detector of potential risk and mitigation in the pursuit of quality through data analytics.
- Familiar with Key Risk Indicator thresholds and creation of study-specific Key Risk Indicators.
- Advanced ability to analyze complex business / technical / clinical situations from reviews of protocols and other such study documents or data analytics tools to determine potential effects.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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