Clinical Supplies Manager
Posted on: May 28, 2023
- This position will assist and support Associate Director in
managing Contract Development and Research Organizations (CDMO) in
the areas of Clinical Trial Material (CTM) manufacturing. The
management of these activities involves review of master batch
records (MBR), Master Packaging Work Orders (MPWO), protocols, and
reports; documentation, archiving, and processing internal and
external change controls, preparation of data tables when needed
for data interpretation
- The candidate will also be supporting management of clinical
supply inventories and manage IRT/IVRS. The candidate is expected
to communicate with Clinical Operations on routine basis to
understand the current and future scope of the clinical trial and
convey the clinical supplies need to plan future manufacturing,
packaging, and labeling. Experience in use of related software
tools is expected.
- This position is expected to verify completion of work, manage
and process invoices and internal project budget requests (ARIBA),
and monitor work specific budget.
1. Technical Management
- Manage study specific US and global /ROW clinical supply
- Assist and prepare CRO/CMO Vendor Comparison slides and assist
in the selection of an appropriate CRO/CMO
- Provide technical support for vendor's IRT/IVRS system in
support of SK projects
- Utilize inventory management and forecasting software to ensure
adequate amount of CTMs are available to supply clinical
- Review manufacturing, packaging, and labeling Master and
Executed Packaging Work Orders/Batch Records, Packaging Labeling
Approval Forms (PLAF) and Labeling Approval Forms (LAF)
2. Financial Management
- Prepare requests for proposals for the clinical supply
projects; including preparation of Ariba PR and PO, and PR-Amend of
Clinical Supply proposals, contracts change of scope, SOWs
- Review CRO/CMO Project proposals and provide feedback to
manager prior to selecting the vendor; review and audit slides,
tables, and budget calculations
- Prepare Ariba process for internal budget approval of
new/ongoing CMC Team projects
- Prepare, maintain, and monitor project budgets for CMC
- Review and process clinical supply CMO invoices for project
- Prepare and assist FP&A team on project specific spending
and accrual monthly and quarterly base, if requested.
- Participate in project budgeting and forecasting process for
the CMC Team annual project budget management activities
3. Additional Responsibilities
- Assist in archiving of clinical supply documents
- Assist in writing and preparation of regulatory submission
documents: drug product and drug substance sections in IND, Annual
reports, and Informational amendments
- Assist in writing and preparation of SOPs and interpreting and
review of SOPs and protocols
- Bachelor's degree up to 5 -8 years' experience working in a in
clinical supplies environment.
- Ability to understand, maintain and demonstrate troubleshooting
on vendor's IRT/IVRS system.
- Ability to read, analyze, and interpret basic scientific
protocols, reports, and technical journals. - Also, should be able
to interpret financial reports.
- Expert technical skills, good organization skills, ability to
follow directions and have good communication skills. - Computer
aptitude a plus, especially proficiency with Microsoft Office, in
particular use of Excel.
- Understand protocols, write SOPs, and technical knowledge of
packaging and labeling activities.
- Knowledge of pharmaceutical stability protocols, assessment of
expiration dating for investigational drug products
- Knowledge of GMP batch record development, review, and approval
- Demonstrated understanding of entire supply chain and
associated cost drivers
- Experience that would be a plus:
- Ability to execute Clinical Supply portion of User Acceptance
Testing (UAT) for IRT system.
- Knowledge of GCP and global cGMP regulations, (knowledge of EU
GMP QP regulations is preferred).
- Knowledge of warehousing, distribution (including cold chain
distribution), and logistics.
- Ability to review, analyze and interpret the IVR/IRT reports
and specification requirements.
- Experience in using inventory and forecasting software.
- Ability to work on multiple projects at a time
- Makes effective goal-oriented decisions
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of
effective verbal communications
- Ability to examine and observe details
Keywords: UNAVAILABLE, Paterson , Clinical Supplies Manager, Executive , Paramus, New Jersey
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