Clinical Operations Manager

Summary

Join AbbVie's clinical research team as a leader, driving excellence and impacting patient lives. You will build and manage high-performing teams, ensuring on-time and within-budget delivery of clinical studies. Responsibilities include strategic planning, oversight, performance management, and mentoring of team members. You will ensure adherence to regulations and best practices, manage resources and budgets, and foster a collaborative environment. This remote East Coast position requires strong leadership, communication, and organizational skills, along with experience in clinical research monitoring. AbbVie offers a comprehensive benefits package.

Requirements

• Bachelor's or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
• Minimum 3 years of monitoring experience
• Excellent interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally
• Demonstrate flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships
• Demonstrate proactive and positive team player attributes
• Exhibit strong planning and organizational skills
• Possess experience across multiple therapeutic areas and study phases
• Demonstrate mentoring and coaching skills
• Have the ability to provide transparent and timely feedback to raise the bar on individual and team performance
• Drive innovation and continuous process improvement
• Act with integrity in accordance with AbbVie code of business conduct and leadership values
• Deal comfortably with risk and ambiguity, changing course when needed
• Have the ability to make timely, high-quality decisions based on available data and information
• Have the ability to work independently and take initiative/ownership
• Have the ability to adapt and move quickly

Responsibilities

• Build and lead high performing clinical research teams who partner with investigative sites for meaningful and effective engagements, striving to position AbbVie as the partner of choice in clinical trials
• Provide strategic planning, oversight and direction of the team to ensure on time, within budget and quality delivery of clinical studies
• Establish partnership with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R&D portfolio success
• Hire, retain, manage performance, mentor, assign tasks, and foster the growth and development of their clinical research team
• Provide leadership and oversight to the clinical research team including, but not limited to: performs accompanied visits (on-site and off-site); accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders; conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel; addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics
• Utilize AbbVie systems and tools to support assigned personnel to proactively address performance and mitigate risks
• Proactively identify individual needs of their team members, remove obstacles, propose solutions, and tailor support to enable successful, on-time monitoring and / or delivery of their assigned study activities
• Ensure adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research
• Stay abreast of new and/or evolving local regulations, guidelines and policies
• Support, train, and oversee assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies
• Prepare and follow up on site and country audits, CAPA preparation and implementation
• Manage resources for assigned team, utilizing reports from available systems and country/area model to accomplish; In alignment with AbbVie research goals, priorities, an specific study timelines; Ensure resource utilization to address business priorities and maximize team impact to delivery of the pipeline
• Manage the budget and payments of the assigned studies conducted by their assigned team, as applicable
• Create an inclusive environment to enable team members to reach their full potential
• Help team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline
• Lead and support the team to understand the business strategy and vision
• Drive and implement change through effective communication and management
• Participate and/or lead global/local task forces and initiatives
• Perform activities as assigned by Line Manager
• Proactively identify opportunities at local/ global levels and proposes solutions to create efficiencies and streamline/improve processes
• Partner with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials
• May be assigned TA responsibility within an affiliate
• Support training and Monitoring for team, develop and implement strategies to support Site and key opinion / National leader identification (including feasibility) to support AbbVie pipeline execution within the Country or Region
• Work with affiliate teams (including Medical Affairs and Commercial brand teams where appropriate) for assigned TA's

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs