R&D Operations Manager: Biospecimen Operations

Career Category

Project Management

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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 Operations

Live

What you will do

Let’s do this. Let’s 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 position’s 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:

Master’s degree and 3 years of industry experience in clinical trials and/or biospecimen management

Or

Bachelor’s degree and 5 years of industry experience in clinical trials and/or biospecimen management

Or

Associate’s degree and 8 years of industry experience in clinical trials and/or biospecimen management

Or

High school diploma / GED and 10 years of industry experience in clinical trials and/or biospecimen management

Preferred Qualifications:

• 7+ years work experience in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories
• Knowledge and functional expertise in R&D, particularly specimen and data management
• Knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), ICH and FDA guidelines for clinical trials
• Evidence of strong project management skills
• Exceptional verbal and written communication skills and experience navigating a matrixed organization
• Experience with Laboratory Information Management Systems (LIMS)
• Working knowledge of document management applications and study planning tools (eg. Planisware, SmartSheet, Tableau, Veeva platform, etc)
• Ability to develop collaborative internal and external relationships
• Excellent interpersonal, organizational, and critical thinking skills

Thrive

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 comprisin