Senior Biomarker Program Manager

7 days ago

Waltham, Massachusetts, United States AbbVie Full time
Job Title: Senior Biomarker Program Manager

AbbVie is seeking a highly skilled Senior Biomarker Program Manager to join our Precision Medicine Biomarker Program Management (BPM) group. As a key member of our team, you will play a critical role in implementing and managing biomarker research in multiple Phase 1-3 clinical trials.

Key Responsibilities:
  • Manage biomarker operations and logistics to align with clinical trial schedules
  • Collaborate with lead biomarker scientists to provide regular updates to cross-functional stakeholders
  • Oversee clinical study documents and associated systems, including protocols, informed consent forms, eCRFs, and CSRs
  • Ensure consistent responses to EC/IRB biomarker-related inquiries while maintaining AbbVie biomarker standard language and study timelines
  • Manage biomarker vendor selection and research scope, contract execution, and vendor oversight in compliance with AbbVie processes and regulations
  • Forecast and track study costs associated with sample and result management, bioanalytical assays, logistics, and shipping
  • Develop and deliver study-related training for the study team, study sites, and vendors
  • Oversee sample analysis and data transfer, ensuring timely shipments to vendors and/or storage sites and accurate data transfer to correct databases
  • Manage sample management, storage, and/or destruction per requirements
  • Deposit biomarker-related documents to the Trial Master File, ensuring documentation standards are followed and are 'inspection-ready'
  • Proactively identify and resolve 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 process improvement initiatives or improving efficiency as needed, as well as 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
Requirements:
  • PhD degree with a life sciences background, including biomarkers, and 4+ years of project management and/or clinical operations experience
  • Master's degree with a life sciences background, including biomarkers, and 9+ years of project management and/or clinical operations experience
  • Bachelor's degree with a life sciences background, including biomarkers, and 12+ years of project management and/or clinical operations experience
  • 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
Preferred Qualifications:
  • 2+ years of direct clinical/biomarker operation experience, with exposure spanning initiation through study completion
  • Competent in the application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
  • Knowledge of biomarkers, 6+ years of project management and/or clinical operations experience desirable
  • Ability to work with minimal supervision
  • Experience holding meetings by teleconference and working with colleagues remotely
  • Ability to work effectively in a cross-functional team environment and interact with various levels within the organization as well as vendors
  • Project Management certification is a plus
Key Leadership Competencies:
  • Builds strong relationships with peers and cross-functionally with partners outside of the 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

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