Manager, Clinical Research Pharmacy Services
Thousand Oaks, California
Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT
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Career Category Clinical Job Description HOW MIGHT YOU DEFY IMAGINATION? Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role. Manager, Clinical Research Pharmacy Services Live What you will do Lets do this. Lets change the world. In this vital role you will work in partnership with GCPM and Early Development to develop 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 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 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 Win 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: – Doctorate degree Or – Masters degree and 3 years of clinical or scientific experience Or – Bachelors degree and 5 years of clinical or scientific experience Preferred Requirements: – Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech or pharmaceutical company – 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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. Equal Opportunity Statement 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 a 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 an accommodation. #GDO2021 .