Sample Operations Manager I, Biomarker - 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

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

This position offers the flexibility to work onsite for a minimum of three days a week in either North Chicago, IL or South San Francisco, CA.

Responsibilities:

• Manage the biomarker operations and logistics to align with clinical trial schedule
• Co-manage with Biomarker Program Manager and 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.)
• Respond to 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; managing contract execution and vendor oversight in compliance with AbbVie processes, procedures and applicable regulations
• Support LIMS management via testing as needed
• Contributes to the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed Contributes to generation of 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 sample 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
• Learn to 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
• Develop into a subject matter expert (SME) and resource for one or more processes in BPM
• Participate in process improvement initiatives for 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:

• Master’s Degree with 4+ years project management, oncology and/or clinical trial experience or Bachelor’s Degree with 6+ years of project management, oncology and/or clinical trial experience
• Minimum 2+ years direct clinical trial management experience, with exposure spanning initiation through study completion
• Scientific background and knowledge of oncology
• Ability to work with minor 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
• 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
• PMP certification a plus

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html