Central Monitor Manager

AbbVie Inc.; Warszawa; Presencial; PLN 431.000 - 821.000; Jornada completa

Descripción de la vacante

AbbVie Inc. is seeking a Central Monitor Manager to lead a global team delivering best-in-class central monitoring within the RBQM framework.

You will ensure on-time, high-quality execution across multiple studies and therapeutic areas, aligning strategies with regulatory expectations and AbbVie's standards. The role requires RBQM expertise, strong leadership, and collaboration with cross-functional partners to optimize processes, staffing, budgeting and performance development in a fast-paced

Formación

• Bachelor's degree in related field, may include life sciences, risk-based discipline.
• Minimum of 6 years of clinically related experience or data trend analysis experience, 4 years in study operations with some people management experience (remote experience preferred).
• Experience working in an RBQM-model or similar experience with risk-based monitoring preferred.
• Experience/exposure to drug development, operations, risk management, successful decision-making, strategic execution, in a fast-paced environment.
• Strong current knowledge of applicable therapeutic indications, regulations, and ICH/GCP guidelines as they relate to the conduct of clinical trials.

Responsabilidades

• Delivering on best-in-class central monitoring, while driving financial/headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.
• Partnering with study teams to drive the implementation of the aggressive execution strategies.
• Line management of Central Monitors, including staffing, development of high performing teams, contracting, budgeting, hiring, performance reviews, and mentoring.
• Utilizes deep understanding of central monitoring and risk evaluation to support front-line staff and strengthen collaboration with Clinical Site Management and cross-functional stakeholders.
• Contribute to ongoing development/advancement/improvement of the RBQM systems – providing requirements that will further enable near-real time data analysis to ensure quality.
• Be an RBQM champion across AbbVie, supporting RBM processes across cross-functional teams spanning the R&D portfolio.
• Support and contribute to the development and health of the necessary business processes to support risk mitigation and global monitoring.
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.

Educación

Bachelor's degree in related field

Descripción del empleo

• Compensation: USD 109,500 - USD 208,500 - yearly

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The Central Monitoring and Risk Management is at the heart of AbbVie’s end-to-end RBQM model - a critical pillar required in AbbVie’s mission to be a world-class R&D organization.

The Central Monitor Manager is responsible for managing a cohesive team of front-line central monitor staff to deliver best-in-class central monitoring execution. They ensure central monitoring in clinical research studies are executed on-time with quality and efficiency, ensure that the strategies and tools selected are implemented appropriately, and ensure best practices are maximized to drive execution. They are responsible for managing processes/programs in multiple countries and across multiple Therapeutic Areas. They will ensure an inclusive, learning, and innovative environment that sets up central monitors and their assigned studies for success.

The Central Monitor function is de-centralized and includes team members from across the globe. Central Monitor Managers are responsible for staff across the globe.

Responsibilities:

• Delivering on best-in-class central monitoring, while driving financial/headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.
• Partnering with study teams to drive the implementation of the aggressive execution strategies
• Line management of Central Monitors. Resourcing, development of high performing teams, contracting, budgeting, hiring, performance reviews, and leading talent development of staff, including linking the “why” and bigger picture, elevating team to think more strategically, creating a culture of challenging the status quo to drive efficiencies and innovation, bringing ideas from outside of AbbVie, inspiring the team, and creating an inclusive and supportive environment in which staff are empowered to achieve peak performance.
• Utilizes deep understanding of central monitoring and risk evaluation to support front-line staff and strength in influencing/partnering to build trust with Clinical Site Management, Clinical Development Operations (CDO) and cross-functional stakeholders.
• Contribute to ongoing development/advancement/improvement of the RBQM systems – providing requirements that will further enable near-real time data analysis to ensure quality.
• Be an RBQM and 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). Advises when updates are needed.
• 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
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.

Education & Experience

• Bachelors degree in related field, may include life sciences, risk-based discipline.
• Minimum of 6 years of clinically related experience or data trend analysis experience, 4 years is required in study operations with some people management experience (remote experience preferred).
• Experience working in an RBQM-model or similar experience with risk-based monitoring preferred.
• Experience/exposure to drug development, operations, risk management, successful decision-making, strategic execution, in a fast-paced environment.
• Strong current in-depth knowledge and understanding of 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).

Make Possibilities Real

• Collaborating in cross-functional global team environment.
• Remove obstacles and provide supports that enables direct reports to achieve results.
• Successful coaching/ mentoring, directly and in a matrix environment.

Clear & Courageous

• Respectfully provides transparent, accurate and timely feedback to help direct reports improve performance.

Analytic & Critical Thinking Skills

• Strong analytical skills, critical thinking, functional expertise and good judgement and the ability to evaluate complex issues from multiple perspectives and drive SMART SURE decision making and timely outcomes.
• Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner

Interpersonal & Communication Skills

• Acts with integrity in accordance with ABBVIE code of business conduct.
• Evangelist for RBQM within the organization, promoting value of early detection in de-risking studies.
• Strong English language skills - spoken, written, and conversational.
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility, and adaptability to changing requirements, resourcefulness, and creativity. Demonstrated proactive and positive team player.
• Lead dynamic meetings and create engaging presentations.
• Able to maintain calm, cool, collected, and competent composure in high pressure situations in order to ensure successful hand-off to stakeholders responsible for taking action.
• Open and receptive to the gift of feedback in the pursuit of continuous improvement.

Organizational Skills

• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.

Computer Skills

• Comfortable with use/operation of data analytics and visualization tools for oversight.
• Competent with Microsoft Office applications (Outlook, Word, Excel, PowerPoint, and Teams)

Key Stakeholders:

Peers & Colleagues: Clinical Site Management (CSM); Clinical Study Leadership (CSL); Strategic Clinical Operations; Therapeutic Area Medical Directors (TA MDs); Data Science Strategy & Operations; Data Analytics; Clinical Trial Patient Safety; Compliance.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.