Companion Diagnostics Sample Operations Manager

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.

CDx Sample Operations Manager

AbbVie is currently offering a unique opportunity for a highly motivated individual to join our team as a CDx Sample Operations Manager. We are seeking a creative and highly motivated individual to join Precision Medicine, which supports CDx development across AbbVie. This group is responsible for the oversight and execution of CDx development. The CDx Sample Operations Manager will facilitate science-based decision making by successfully managing biospecimen logistics for CDx development. The successful candidate will have scientific expertise, CDx expertise and be experienced with strategic thinking and cross-functional collaboration.

Key Responsibilities:

• The CDx Sample Operations Manager will work closely with CDx Operations managers to act as the primary point of contact for biosample logistics with internal and external partners (Abbvie Translational Groups, Abbvie CPD, external testing labs and CDx vendors).  This work will include:
  • Receiving, managing, and fulfilling requests for samples and sample-associated data such as slide images.
  • Uploading of subject-level data and informed consents into LIMS.
  • Coordinate shipment of clinical trial biospecimens from CRO labs or other AbbVie locations.
• The CDx Sample Operations Manager will be responsible for the physical receipt, storage, inventory, and shipping of samples (unstained slides, stained slides, images, other sample types) and chain-of-custody monitoring.  This work would include:
  • Being the primary contact for deliveries
  • Receiving and unpacking deliveries, reconciling against sample manifests, uploading status updates into LIMS, resolving discrepancies
  • Interaction with LIMS vendor or internal LIMS support team
• Coordinate sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to the correct databases
• Responsible for sample management, storage, and/or destruction per requirements
• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines. Serve as a subject matter expert (SME).

Qualifications

Requirements:

• Bachelor’s Degree with 2+ years of project/sample management, oncology, CDx and/or clinical trial experience
• Expertise in MS Office applications including Excel, Word and PowerPoint
• Expertise in LIMS
• Excellent verbal communication and interpersonal skills are required
• Strong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment.

Preferred:

• Minimum 2+ years direct clinical trial sample 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. Knowledge of oncology and CDx 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

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
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.