Sample Operations Manager I Biomarker
Sample Operations Manager I Biomarker
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1 Vacancy
Job Description
The Biomarker Sample Operations Group at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to further AbbVies innovative pipeline. The Sample Operations Manager connects science and operations to support biomarker research for multiple Phase 13 clinical trials. This role will manage operational and logistical strategies ensuring clinical trials are executed with quality and efficiency ontime within budget and meet objectives. The Sample Operations Manager achieves these objectives via scientific expertise strategic thinking a global mindset and crossfunctional collaboration.
This position offers the flexibility to work onsite for a minimum of three days a week in either North Chicago IL or Waltham MA.
Responsibilities:
- Manage the biomarker operations and logistics to align with clinical trial schedule
- Comanage with Biomarker Program Manager and lead biomarker scientist to support regular updates to crossfunctional 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 inspectionready
- Learn to identify and resolve and/or escalate studyrelated issues
- Apply and adhere to ICH/GCP biostorage procedures biosample 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 fastpaced teambased environment and work independently when needed
Qualifications :
Qualifications:
- Masters Degree with 4 years project management oncology and/or clinical trial experience or Bachelors 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 crossfunctional 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
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 shortterm incentive programs.
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 AbbVies 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
