Manager, Clinical Research Pharmacy Services
Amgen
Hong Kong, HK
6天前

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have.

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.

Become the professional you are meant to be in this meaningful role.

Manager, Clinical Research Pharmacy Services

What you will do

Let’s do this. Let’s change the world. In this vital role you will work in partnership with Global Clinical Program Management (GCPM) and Early Development to develop Investigational Product (IP) documentation and training, to monitor dosing deviation / pharmacy trends and risk indicators, and to support CRPS annual goals and process improvement initiatives.

Support the annual review and update programs for Investigational Product Instruction Manuals (IPIMs) and IP Documentation

  • Act as First Point of Contact for Sites and Internal Partner queries on IP administration, formulation preparation, labeling and / or packaging
  • Lead Presentations for IP information at Investigator Meetings and Site Initiation Meetings
  • Support the Clinical Research Pharmacy Services (CRPS) Senior Managers on Program Strategy and Continuous Process Improvement Initiatives
  • Review and trend Dosing Deviations and Root Causes at Study, Program and Portfolio level to identify risk indicators and mitigation plans
  • Support internal partners & networks to promote greater cross functional understanding and insight into clinical IP needs, IP presentation and preparation challenges
  • Maintain a good working relationship with external depots (e.g., GCSCM ABR and ATO) and clinical logistics
  • Lead Presentations on behalf of CRPS with cross-functional partners speaking to new initiatives related to IP development and management
  • Be part of our Clinical Research Pharmacy Services Team :

    The Clinical Research Pharmacy Services team is a highly talented group of Investigational Product Preparation and Administration specialists dedicated to oversight of Investigational Product in Amgen Studies.

    This team has an intimate understanding and insight into trial site practice, provides Investigational Product clinical services and relays how Investigational Product should be handled and managed within clinical sites.

    The team drives and contributes to continuous process improvement relating to Investigational Product.

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The self-confident professional we seek is a partner with these qualifications.

    Basic Qualifications :

  • Registered Pharmacy Technician with the General Pharmaceutical Council (GPhC) OR Registered Pharmacist
  • Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials
  • Preferred Requirements :

  • Practical experience in a clinical research setting working on complex clinical programs in a pharmacy at an investigational site
  • Experience with drug formulations, sterile product compounding and administration practices
  • Relevant therapeutic area education (oncology preferred) and training
  • Knowledge of ICH / GCP regulations and guidelines
  • Strong knowledge of clinical trial operations
  • Computer and system operation skills
  • Demonstrated ability to anticipate and resolve problems
  • Ability to write, communicate and present clearly using scientific and clinical issues terminology
  • Thrive

    Some of the vast rewards of working here

    As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work / life balance, and career benefits with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
  • Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.

    careers.amgen.com

    Equal Opportunity Statement

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