Sr. Drug Supply Manager at Hanover

Job Description

Responsibilities:

• Plans, establishes, manages, monitors and performs activities related to preparation and distribution of supplies for US local Phase 4c studies, working with clinical team and approved vendors, in compliance with internal procedures and GxP requirements.
• Leads the planning, creation, distribution and maintenance of clinical supplies for US Phase 4c studies
• Coordinates randomization, packaging, labeling and distribution of clinical supplies with clinical team and approved vendors as per the approved study design.
• Accountable for creating eCPRs with good quality, ensures that key study milestones are met.
• Establishes the packaging design based on protocol
• Manages all packaging activities including Work Order creation, review and approval of contractor packaging records and monitoring work at contractors
• Responsible for materials and inventory management of supplies for US local Oncology studies.
• Timely communicates and updates clinical supply plan on study level to SCMs, ensure seamless coordination on demand/supply plan.
• Authorizes destruction of outdated material
• Manages all finance activities with clinical team including Request for proposal for bidding and vendor selection, purchase orders and invoice approval
• Supports internal/external inspections and audits.
• Creates reviews and updates the demand plans based on strategic elements/study forecasts.
• Contributes to specifications with support for IVRS set up Supports clinical team with medication management for IVRS studies
• Reviews clinical trial protocol and provides input to drug sections.
• Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage.
• Triggers label design process, leads packaging design and optimization, coordinates the randomization and distribution of clinical supplies according to study design.
• Coaches other team members on specific topics (e.g. packaging design, finance etc.)
• Establishes contact network with client approved contractors and vendors
• Primary liaison with contractors for external packaging and distribution campaigns
• Establishes and manages supply related timelines with other groups as DSM, QA, and PHAD, to ensure agreed timelines are met 

Job Requirements

Requirements:

• Excellent communication skills
• Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience

 

Education 

• BA/BS

 

 

Qualified candidates, please send current Word resume to: [Click Here to Email Your Resum] for immediate consideration.

 

 

 

Country: USA, State: New Jersey, City: Hanover, Company: Scistaff Services LLC.