Sr Clinical Supply Manager
Company: DSJ Global
Location: San Mateo
Posted on: May 25, 2023
Onsite- 3 days per week (San Mateo, CA or Carlsbad, ca)MUST
HAVE- Clinical supply phase 1-3 experienceResponsibilities
include:Supports end-to-end clinical supply responsibilities
including but not limited to protocol interpretation, demand
planning, supply planning, distribution, inventory management,
label generation, and planning and execution of labeling operations
at partner contract manufacturing organizations (CMOs).
- Carries out operational/logistics strategies and works with
CSCM, Quality Assurance, and other functional groups to execute
strategies that ensure on-time & safe delivery of all clinical
- Ensures accurate inventory records at all depots through timely
- Keeps abreast of all incidents related to shipment and reports
trending to Quality Assurance and assists in creating CAPAs
- Responsible for maintaining GDP, GMP, and global trade
- Collaborate with Logistics management and other members of
CSCM, PDM, and external partners to resolve shipping related
issues; Escalates to senior leadership as needed
- Revise and author SOPs and Work instructions with manager
direction and support
- Obtain and review quotes, approves purchase requisitions and
- Implement business strategies in-line with the vision and goals
set forth by the department Ensures priorities are being met and
creates clear work plans for staff; communicates progress
- Typically recruits, onboards, develops, retains, and supervises
staff; sets clear goals for individuals.Knowledge and Skills:
- Possess strong clinical supplies management experience/
knowledge in forecasting, demand/supply planning, IRT systems,
inventory management, clinical labeling, distribution including
cold chain, import/export, reverse logistics, CMC and GXP
- Possesses collaboration, influencing, and negotiation skills to
work effectively with internal cross-functional groups and external
suppliers to meet the aggressive clinical study timeline and
- Possesses experience with clinical blinding practices in global
studies, from Phase 1 to Late Phase.
- Possesses solid experience in sourcing and managing comparator
drugs and other co-meds for clinical studies.
- Mature knowledge of the FDA, cGMP, GCP standards and regulatory
- Works well with ambiguity, can assess options quickly and
efficiently implement the best option in alignment with Gilead's
culture and expectations for clinical timelines.
- Excellent verbal, written, and interpersonal communication
skills are required. Must have the ability to write clear, concise,
and error-free documents/presentations.
- Strong computer, database and organizational skills required.
ERP, Planning System, and Project management experience is a
- Able to manage the resources and timelines for programs of
moderate complexity.Education and Experience: - 7+ years of
relevant experience and a Bachelor's degree - 5+ years of relevant
experience and a Master's degree - 0+ years with PHD or PharmD
- - Degrees in the sciences preferred
Keywords: DSJ Global, San Mateo , Sr Clinical Supply Manager, Healthcare , San Mateo, California
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