Company Description
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.
Job Description
As China (Senior-) Precision Medicine Operation Manager, you will provide operational expertise to consistently implement the operational delivery of Precision Medicine strategies of clinical trials conducted in China, ensuring timely delivery of testing lab readiness, quality data and audit readiness at all times. You will be responsible for ensuring the appropriate level of sample and assay quality, defining corrective actions if necessary, and escalating issues when appropriate.
Key Responsibilities:
- Provide operational expertise to implement clinical biomarker and diagnostic strategies within clinical trials in China, ensuring timeline and audit readiness.
- Ensure appropriate sample and assay quality, define corrective actions for study issues, and escalate issues as necessary.
- Accountable for sample management strategy deployment and manage key activities with laboratory partners, including technical qualification, sample analysis plans, validations, and analytical reports.
- Ensure all activities are completed within time, quality, and budget requirements, aligned with agreed sample and assay management strategy.
- Provide regular study-level status updates for areas of accountability/responsibility to key stakeholders.
- Provide expert input into Clinical Trial documentation, including Protocols, Informed Consent Forms, data transfer agreements, lab manuals, and lab specifications.
- Proactively identify challenges across the sample, assay, and data operations space impacting the delivery of China Precision Medicine strategy.
- Create and deliver solutions for simplifying sample, assay and data operations practices to increase productivity, maximize value, and remove redundant activities.
- Ensure compliance with all company policies and procedures relating to HGRAC regulation, Human Subject Research, Individual Human Data, and good data practices.
- Contribute to functional process and system improvements to ensure operational excellence.
- Support other activities as required.
Qualifications
Basic Qualifications:
- Bachelor’s degree in a science or health-related discipline.
- Experience in clinical trial specimen management, including collection/processing of diverse sample types, laboratory management, LIMS, and project management.
- Demonstrated knowledge of the clinical development process, GxP, and global and China-specific regulatory requirements for sample analysis, including sample exportation.
- Excellent communication skills, interpersonal skills, and matrix working skills.
- Self-motivated with the ability to work independently, as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team, including internal and external technical and business experts.
- Demonstrated attention to detail.
Preferred Qualifications:
- Master’s degree, or equivalent experience.
- Experience with managing the generation and flow of high-dimensional biomarker datatypes (e.g., IHC, imaging, NGS, proteomics).
- Experience with validation and implementation of biomarkers.
- Experience with clinical biomarker and diagnostic development.
- Good understanding of scientific R&D processes.
- Familiarity/knowledge of data governance and privacy considerations regarding the use and re-use of human subject data.
- Experience in clinical data management, quality, and governance, or external collaborative engagements.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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https://www.abbvie.com/join-us/reasonable-accommodations.html