Biomarker Project Manager II (Glen Ellyn)

Employment Type

: Full-Time

Industry

: Non-Executive Management



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The Translational Oncology group at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to further AbbVie's innovative Oncology pipeline. The Biomarker Project Manager II connects science and operations to manage biomarker research for multiple Phase 1-3 clinical trials. This role will employ operational and logistical strategies ensuring clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and cross-functional collaboration.

Key Responsibilities:
  • Manage the biomarker operations and logistics to align with clinical trial schedule
  • Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial
  • Key contributor of 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
  • Support 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
  • Coordinate sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases
  • Responsible for samples management, storage, and/or destruction per requirements
  • 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 improving efficiency as needed, as well as instructions and manuals for internal training purposes
  • Manage multiple contract or permanent employees as 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


Basic:
  • Master's Degree with 6+ years project management, oncology and/or clinical trial experience
  • Bachelor's Degree with 8+ years of project management, oncology and/or clinical trial experience
  • Expertise in MS Office applications including Excel, Word and PowerPoint
  • Excellent oral and written communication skills in English
  • Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills


Preferred:
  • PMP certification a plus
  • Minimum 2+ years direct clinical trial management experience, with exposure spanning initiation through study completion
  • Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
  • Scientific background and knowledge of oncology
  • 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


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


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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