Clinical Research Specialist / Manager
United Kingdom – Uxbridge; United Kingdom – Cambridge
Clinical Research Specialist (Pharmacist /Technician /Nurse)
The Amgen Clinical Research Pharmacy Services team is looking for an experienced Clinical Research Specialist to join our expanding team of Health Care Professionals.
The Clinical Research Pharmacy Services team supports Amgen’s diverse portfolio of Investigational Products and currently has a vacancy for an experienced Investigational Product Pharmacist or Pharmacy Technician or Clinical Research Nurse. As an accomplished Clinical Research Specialist, you will support Amgen’s portfolio of Clinical Trials and provide guidance and support to internal groups and clinical sites on clinical trial preparation and administration methods.
If you are looking for your next career step within Investigational Product Management and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/
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.
Clinical Research Specialist role overview:
Working within Global Development Operations, the Clinical Research Pharmacy Services Manager will support Global Clinical Program Management (GCPM) and Early Development (ED) to develop Investigational Product (IP) documentation and training and assist with the resolution of IP quality issues across sites. Monitoring dosing deviation/pharmacy trends and risk indicators, you will also partner with process development and Global Clinical Supply Chain Management (GCSCM) to optimize labelling and packaging of IP and provide insight into how IP is handled at clinical sites.
- Support the development of:
- All new study Investigational Product Instructional Manuals (IPIM) (excluding First in Program studies)
- All new IP supporting documentation (Dose Preparation Worksheets/Dose Calculation Worksheets)
- Site Evaluation, Initiation and IP Training Information
- Product Attribute Forms (PAFs)
- Support the annual review and update programs for IPIMs and IP Documentation
- Act as First Point of Contact for Sites and Internal Stakeholder queries on IP administration, formulation preparation, labelling 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 stakeholders & 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 stakeholders speaking to new initiatives related to IP development and management
Qualifications and minimum required experience:
- Registered Pharmacy Technician OR Registered Pharmacist with the General Pharmaceutical Council (GPhC) OR Registered Pharmacist OR Registered Nurse with the Nursing and Midwifery Council (NMC)
- Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials
- 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
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
About our company:
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
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