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R&D Operations Manager: Biospecimen Operations
2 months ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
R&D Operations Manager: Biospecimen OperationsLive
What you will do
Lets do this. Lets change the world. As a member of the Biospecimen Operations team, you will be responsible for supporting biospecimen management activities using the LIMS system for all clinical and nonclinical programs and contribute toward optimizing system capabilities to enable successful completion of study milestones. You will be the technical subject matter expert and serve as a key resource for issue resolution, questions, and best practices. To achieve this, the manager is a creative problem solver who can deliver relevant results that keenly drive productivity and efficiency. Some of the positions key responsibilities include participating in the following activities:
- Manage complex study set up in the LIMS system to support clinical trials under Good Clinical Practices (GCP)
- Assist in study start-up activities including review of central lab statement of work, review of data transfer plans, act as point of contact for central lab management file transfers
- Develop data transfer templates for Clinical Data Management and support continuous improvement
- Act as escalation point to manage issues related to specimen and results management
- Oversee specimen and data management activities in support of clinical milestones (snapshots, database locks, etc.)
- Identify process gaps in specimen management and make recommendations for continuous improvement with a focus on cost savings and turn-around time
- Assist with ongoing data cleaning and data discrepancy resolution in LIMS
- Manage specimen storage vendors and other suppliers as required
- Work directly with internal and external partners to create strategy in line with evolving business needs
- Manage specimens from nonclinical studies under Good Laboratory Practices (GLP)
- Manage external workers and serve as escalation point related to external worker roles and responsibilities
- Actively serves as the functional lead to other strategic and process improvement initiatives across internal and external organizations.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong collaborator with these qualifications.Basic Qualifications:
Masters degree and 3 years of industry experience in clinical trials and/or biospecimen managementOr
Bachelors degree and 5 years of industry experience in clinical trials and/or biospecimen managementOr
Associates degree and 8 years of industry experience in clinical trials and/or biospecimen managementOr
High school diploma / GED and 10 years of industry experience in clinical trials and/or biospecimen managementPreferred Qualifications:
- 7+ years work experience in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
