Clinical Operations Manager

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.

• 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 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.
• Utilizes AbbVie 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, 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.

• 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.