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AbbVie Biomarker Program Manager Vacancy – Biological Science

AbbVie Biomarker Program Manager Vacancy – Biological Science

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Job Title: Biomarker Program Manager III

Location: Lake County, United States of America; South San Francisco, United States of America

Department: Research and Development

Job id: 2114277

Elibgility Criteria:

  • Ph.D. degree with 2+ years of projects management, clinical trial experience and biological science background, including biomarkers.Expertise in MS Office applications including
  • Excel, Word, and PowerPoint
  • Excellent oral and written communication skills in English
  • Organization, attention to detail, and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills. Proven ability to work well on teams.

Preferred:

  • 2+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred
  • Competent in the application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics, and Compliance)
  • Scientific background in biology or related. Knowledge of oncology is desirable
    Ability to work with minimal supervision
  • Experience holding meetings by teleconference and working with colleagues remotely
  • Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as vendors
  • Project Management certification a plus

Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functionally with partners outside of team
  • Learns fast, grasps the “essence” and can change course quickly when required
    Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation

Responsibilties:

  • Manage the biomarker operations and logistics to align with the clinical trial schedule
  • Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial
  • Responsible for relevant clinical study documents and associated systems (including trial blueprint/protocol, Informed consent forms, eCRFs, CSRs, etc.)
  • Oversee EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines
  • Manage biomarker vendor selection and research scope; manage contract execution and vendor oversight in compliance with AbbVie’s processes, procedures, and applicable regulations
  • Responsible for the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics, and shipping as needed
  • Responsible for generating study related training for the study team, study sites and vendors for each trial
  • Oversee sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases
  • Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’
  • Proactively identify and resolve and/or escalate study-related issues
    Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices, and ethical guidelines Serve as a subject matter expert (SME) and resource for one or more processes in BPM
  • Spearhead or participate in process improvement initiatives or improve efficiency as needed. Update instructions and manuals for internal training purposes
  • Manage multiple contract or permanent employees if needed
  • Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels
  • Balance multiple priorities in a fast-paced, team-based environment and work independently when needed

AbbVie Biomarker Program Manager

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