Amgen

R&D Operations Manager

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 13, 2021
Ref
R-118607
Required Education
Bachelors Degree
Position Type
Contract

In this key role as a R&D Operations Manager, Biological Sample Management and Biobank, you will come in to help us exceed productivity goals and deliver against our operational goals. Our scale is global and supports our clinical trials around the world. Please join an outstanding team that delivers for our stakeholders!

The Role

As a member of the Biological Sample Management team, you will be responsible for supporting biospecimen management activities utilizing 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 meaningful 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 system 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
  • Manage LIMS system interface activities including inventory management at central labs and storage providers
  • Assist with ongoing data cleaning and data discrepancy resolution in LIMS
  • Monitor incoming data and files from external vendors and resolve discrepancies
  • Monitor health of system interfaces
  • Support system enhancements by translating business requirements into functional specifications for IS to update LIMS system and act as subject matter expert to support implementation of changes
  • Manage specimen storage vendors and other suppliers as required
  • Manage specimens from nonclinical studies under Good Laboratory Practices (GLP).

Basic Qualifications:

Masters degree and 3 years of industry experience in clinical trials and/or biospecimen management

OR

Bachelors degree and 5 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), 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

#GDO2021
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.