Clinical Supplies Manager - Paramus, New Jersey, US
TEKWISSEN ®Job Title: Clinical Supplies Manager
Location: Paramus, NJ, 07652
Duration: 3 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 9.00AM-5.00PM
Pay Rate: $70.00-$74.00/Hr
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arb
...
or, Michigan that offers strategic talent solutions to our clients world-wide.
Job Description:
Summary of Position:
• Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.
• Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents.
• Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product.
• Assist and support the management of clinical supply inventories using Interactive Response Technology.
• Expected to prepare data tables when needed for data interpretation.
• Assist with documentation and process internal and external change controls.
• Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc.
• Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.
• Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).
• Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.
• Assist and support Clinical Operations on document reviews related to the study specifics, such as pharmacy manual, study protocols, investigational brochures, etc.
Responsibilities:
Technical Management
• Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it.
• Prepare requests for proposals for activities in support of clinical supply projects.
• Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations.
• Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time.
• Provide technical support for vendor’s IRT/IWRS system in support of clinical studies.
• Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed.
• Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments.
• Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.
• Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc.
• Assist and prepare Excel tables when needed.
• Assist in the maintenance of SOPs related to reflecting current clinical supply activities.
• Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors.
Financial Management
• Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects.
• Prepare, maintain, and monitor project budgets for the CMC Team
• Review and process clinical supply CMO invoices for project activities.
• Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested.
• Participate in project budgeting and forecasting process for the CMC Team’s annual project budget management activities.
Qualifications:
• Bachelor’s degree