Clinical Operations Manager
AbbVie
- Location
- Minato City, Tokyo, Japan
- Employment
- Full Time
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 94 approvals (FY2023)
- Posted
- 1h ago
About this role
Clinical Operations Manager 正規雇用 Workday Global Grade: 17 会社概要 About AbbVie AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. 求人内容 【Purpose Statement】 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. 【Major 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, 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 and issues • 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. • Accountable for resource management for assigned team, as follows: *Utilizes reports from available systems and country/area model to accomplish *In alignment with AbbVie research goals, priorities, a 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