Clinical Research Pharmacy Services Manager - Remote (JP9755)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Clinical Research Pharmacy Services Manager - Remote (JP9755) Location: Thousand Oaks, CA. (Remote) Employment Type: Contract Business Unit: Clinical Research Duration: 12 months with likely extensions Posting Date: 1/31/2022
3 Key Consulting is hiring a Clinical Research Pharmacy Services Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description & Core responsibilities:
Provide input and support into the design of IP sections of study protocols
Provide input and feedback on drug packaging and labelling proposals for clinical studies
Assist in the development and implementation of preventive actions and process improvement initiatives related to Investigational Product (IP) Management
Support internal stakeholders & networks to promote greater cross functional understanding and insight into clinical IP needs, IP presentation and preparation challenges
Identify and support site challenges related to the clinical preparation, labeling, packaging and administration of IP and bring these issues to the appropriate team(s) within the company for analysis and mitigation
Investigate potential IP risks identified at clinical sites and assist CRA/study teams with resolution and action plans
Pro-actively explore dosing deviation trends and root causes to identify risk indicators and mitigation plans
Identify IP management training needs and develop support tools as required by client and site personnel
Support development and regular review of Investigational Product Instruction Manual (IPIM) template, IPIMs and associated documents
Act as the primary point of contact on behalf of company for study related IP Management questions
Understand the capabilities of the clinical sites to inform internal testing of representative materials and delivery approaches
Participate in Clinical Research Pharmacy Forum with other Big Pharma/Biotech companies
Collaborate with and support GDO stakeholders in responding to IP related audit/inspection queries
Provision of subject matter expert input and support into organization
Basic Qualification: PharmD 3-5 YOE
Why is the Position Open? Supplement additional workload on team
Top Must-Have Skill Sets:
Licensed pharmacist, investigational drug
Clinical trial supply management experience
Hospital pharmacy experience
Employee Value Proposition: The person in this role will gain industry experience and clinical trial process.
Red Flags: Pharmacists with only community pharmacy experience, No clinical trials experuence
Interview process: Minimum2, initial phone screen then group interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.