Clinical Operations Manager

Role Summary

To advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients, and leveraging new capabilities to drive industry leading performance. This role is accountable for building and leading 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. Accountable for teams' clinical trial performance, providing 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.

Responsibilities

• Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
• Provides leadership and oversight to the clinical research team, including accompanying visits (on-site and off-site) and accelerating AbbVie's priority programs through collaboration with internal and external stakeholders.
• Conducts trend analysis and gap assessments to proactively identify training and development opportunities for assigned personnel; addresses gaps effectively to help personnel achieve country and site KPIs and metrics.
• Utilizes AbbVie systems and tools to support assigned personnel, proactively addressing performance, mitigating risks, removing obstacles, and tailoring support to enable successful, on-time monitoring and delivery of study activities.
• Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and quality standards; stays abreast of evolving local regulations, guidelines and policies.
• Supports, trains, and oversees assigned personnel to ensure audit and inspection readiness at sites/studies; prepares and follows up on site and country audits and CAPA preparation and implementation.
• Accountable for resource management for the assigned team; aligns with AbbVie research goals, priorities, and study timelines; ensures resource utilization to address business priorities and maximize delivery of the pipeline.
• Accountable for budget management and payments of the assigned studies conducted by the team; fosters an inclusive environment and promotes collaboration with stakeholders to effectively deliver the pipeline.
• Leads and supports the team to understand the business strategy and vision; drives and implements change through effective communication and management.
• May participate in global/local task forces and initiatives; identifies opportunities and proposes solutions to create efficiencies and streamline processes; partners with research sites to engage 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; supports training and monitoring for the team, develops strategies to identify site leaders (including feasibility) to support AbbVie pipeline execution within the country or region; collaborates with affiliate teams where appropriate.

Qualifications

• Education: Bachelors or equivalent degree, health related (e.g., Medical, Scientific, Nursing, Pharmacy) preferred.
• Monitoring Experience: Minimum 3 years.
• Excellent interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross-functionally. Demonstrates flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships. Demonstrated proactive and positive team player.
• Exhibits strong planning and organizational skills. Experience across multiple therapeutic areas and study phases.
• Mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
• Drives innovation and continuous process improvement.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Deals comfortably with risk and ambiguity, changing course when needed.
• Ability to make timely, high-quality decisions based on available data and information.
• Ability to work independently and take initiative/ownership. Ability to adapt and move quickly.