Clinical Operations Manager

Company Description

Abb Vie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

To advance Abb Vie'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 Abb Vie 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.

• 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, but not limited to:
  • performs accompanied visits (on-site and off-site)
  • accelerates Abb Vie'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
• Utilizes Abb Vie systems and tools to support assigned personnel to proactively address performance and mitigate risks. Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and/or delivery of their assigned study activities.
• Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Supports, trains, and oversees 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.
• Accountable for resource management for assigned team, as follows:
  • Utilizes reports from available systems and country/area model to accomplish
  • In alignment with Abb Vie research goals, priorities, an specific study timelines
  • Ensure resource utilization to address business priorities and maximize team impact to delivery of the pipeline
• Accountable for the budget management and payments of the assigned studies conducted by their assigned team, as applicable. Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Leads and supports the team to understand the business strategy and vision. Drives and implements change through effective communication and management.
• May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Line Manager. Proactively identifies opportunities at local/global levels and proposes solutions to create efficiencies and streamline/improve processes. Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning Abb Vie 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 Abb Vie pipeline execution within the Country or Region. Work with affiliate teams (including Medical Affairs and Commercial brand teams where appropriate) for assigned TA's.

• Education:
  
  Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
• Extensive onitoring Experience
• 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.…