Senior Manager, Pharmacy Support Services
Core
Subject matter expert in investigational product (IP) management and pharmacy operations for clinical trials, guiding best practices for IP handling, preparation, and administration.
Role type
Senior Manager, Pharmacy Support Services
Builds
Clinical trial execution support for biologics and gene therapy programs
Domain
Biopharma / Clinical Research
Deliverable
client delivery
Required skills
Sterile product preparation, infusion-based drug administration, biologics expertise, clinical supply chain management, GCP/ICH regulatory compliance, risk mitigation, training module development, cross-functional collaboration
Preferred skills
Cell and gene therapy exposure, PCAB/FDA/USP/NABP/EU CTR guideline familiarity
Technologies
None stated
Responsibilities
Lead pharmacy and clinical trial support including IP preparation and administration; Shape development of pharmacy manuals and training materials; Partner with Clinical Operations and CROs to ensure IP readiness and compliance; Lead Kick-Off Meetings and Site Initiation Visits; Manage ancillary supply compatibility assessments; Provide guidance on IP-related quality assurance issues; Create training modules and mentor new colleagues
Seniority
Senior Manager, strategic leadership & mentorship
