Biomarker Sample Operations Associate

About AbbVie
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. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

POSITION DESCRIPTION:

There is an exciting opportunity in the Translational Oncology group within Precision Medicine at AbbVie. The Translational Oncology group uses advanced methods to discover biomarkers for use in clinical trials. Biomarkers may be used to confirm the molecular targets of a drug, predict efficacy, aid in patient selection and/or inform future drug development strategies. Biomarker research is an essential component for helping serve patient needs and furthering AbbVie's innovative Oncology pipeline. AbbVie is hiring a Biomarker Operations Manager who will connect science and sample operations to implement and then manage biomarker research in multiple Phase 1-3 clinical trials. This role will employ operational and logistical strategies pertaining to sample management to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. This role will drive innovation and continuous improvement in clinical sample collection, processing and transfers and contracting process.

RESPONSIBILITIES:

• Manage the biomarker sample operations and logistics to align with clinical trial schedule
• Engage with Clinical Biomarker Scientists, Project Managers, cross-functional partners, and laboratory vendors to ensure timely and smooth collection, transfer, and testing of clinical trial biospecimens in compliance with protocols, regulatory requirements, and project timelines
• Manage clinical sample receipt, storage, and retrieval while accurately maintaining a sample management LIMS system (StarLIMS)
• Perform sample tracking activities by retrieving reports from various databases (StarLIMS, vendor databases) and filtering reports to select samples for analysis based on varying criteria
• Manage freezers including maintenance activities and sample organization to ensure adequate sample storage
• Review and provide input to study-specific clinical trial documents related to sample operations (collection, storage, transportation, analysis)
• Coordinate sample analysis and data transfer to correct databases by ensuring timely shipments to vendors and/or storage sites
• For each assigned study, engage with Data Sciences team to implement data checks and subsequently reconcile sample collection data, resolve queries, and oversee clinical database locks
• Provide a primary support to facilitate legal and contract agreement requests for execution by working in cross-functionally.
• Facilitates the transformation of the TMF filing system conducted by Clinical Record Management.
• Responsible for sample management, storage, and/or destruction per requirements
• Proactively identify and resolve and/or escalate study-related issues
• Apply and adhere to ICH/GCP, biostorage procedures, bio-sample management best practices and ethical guidelines
• Develop into a subject matter expert (SME) and resource for sample management processes
• Spearhead or participate in sample management process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes
• 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

Qualifications

QUALIFICATIONS:

• Master's Degree with 0+ years project/sample management, oncology and/or clinical trial experience
• Bachelor's Degree with 4+ years of project/sample management, oncology and/or clinical trial experience
• Expertise in MS Office applications including Excel, Word and PowerPoint
• Expertise in sample management LIMS system such as StarLIMS
• 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 Qualifications:

• PMP certification a plus
• Minimum 2+ years direct clinical trial management experience, with exposure spanning initiation through study completion preferred
• 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 is desirable
• Ability to work with minimal supervision

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

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.