Central Monitoring Manager

Company Description

The Manager, Central Monitoring 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 (team of 10-15 people).

Job Description

• 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 and 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.
• 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 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.

Qualifications

• 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 is required in study operations with 1-2 years 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).
• Strong analytical skills, critical thinking, functional expertise and good judgement and the ability to evaluate complex issues from multiple perspectives and drive SMART SURF decision making and timely outcomes.
• Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Comfortable with use/operation of data analytics and visualization tools for oversight.
• 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. Respectfully provides transparent, accurate and timely feedback to help direct reports improve performance.
• Remote role based in: Mexico, Romania, Poland, UK or Ireland.

Additional Information

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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