Central Monitoring Manager

Summary

Join AbbVie as a Manager, Central Monitoring and lead a global team (10-15 people) delivering best-in-class central monitoring in clinical research. You will partner with study teams, manage central monitors, and drive efficient execution strategies. Responsibilities include resource management, talent development, budget control, and contributing to RBQM system advancements. You will ensure compliance and collaborate with cross-functional stakeholders. This remote role is based in Mexico, Romania, Poland, UK, or Ireland.

Requirements

• 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)
• 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)
• 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, Romani, Poland, UK or Ireland

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
• 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/advaneement/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

Preferred Qualifications

• 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
• TA experience preferred in one of the following areas (Neuroscience, Oncology, Immunology, Eye Care, Medical Aesthetics, Women's Healthcare, GI)