Senior Manager, Clinical Trial Supplies, Oncology
Ascendis Pharma
- Princeton, NJ
- $165,000-175,000 per year
- Permanent
- Full-time
- Responsible for complex Oncology IMP/CTS forecasting, inventory management and documentation for complex multi-cohort/product types in Ascendis global oncology clinical trials. Must be adept in Microsoft Excel.
- Manage bulk depot and individual site shipments, track and follow through receipt and release to ensure supplies available to sites at all times with minimal to no waste or missed patient doses.
- Coordinate and responsible for pack/label and distribution activities, review, approve and file related documents.
- Represent CTS oncology with IRT URS development, UAT execution, ongoing monitoring and maintaining of IRT reports to provide weekly drug projections.
- Coordinate CMO planning and drive through approvals for labeling (in multiple languages), packaging, inventory, distribution, and reconciliation/returns/final destruction of IMP/CTS for global clinical studies.
- Manage product complaint processing by gathering information, processing and filing of documentation through disposition.
- Consistently verifies status of clinical trials enrollments and ensures depot and sites inventories are monitored and supplied with IMP/CTS required to ensure continuity of supplies, no missed doses.
- Manage review, drive to approval labeling variable data fields, Packaging Specifications, Product shipping and storage specifications etc.
- Provide broader Clinical Supplies Team with document management & administrative support as required.
- Maintain compliance with all applicable Ascendis CTS SOPs re: CTS handling and management and CTS import / export regulations. SOP and WI writing, as assigned.
- Gather data and maintain applicable metrics to monitor performance relative to clinical trial inventory, and planning.
- Attend meetings and responsible for generating, maintaining, and archiving of team meeting minutes and presented materials, as required.
- Provide general CTS support to other projects and products, as assigned.
- Bachelor's degree in applicable discipline and minimum of 7 years professional experience in CTS pharmaceutical or equivalent biotech industry role.
- Experience in supporting management of complex distribution IMP/CTS supply chains for open label, blinded, double-blinded, placebo-controlled clinical trials in global geographies.
- Strong understanding and knowledge of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies a must.
- Demonstrated abilities and knowledge international regulations governing transport and distribution, import/export of CTS materials.
- Minimal travel on company business may be required.
- Excellent organizational, written, and verbal communication skills.
- Adaptability, agility, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic small company environment.
- Strong interpersonal skills and ability to function in a dynamic cross-functional team environment.
- Strong computer software proficiency in spreadsheets, presentations, and word processing software. Advanced Excel skills are a must.
- Accuracy, compliance, and attention to detail is a must.
- GMP manufacture experience of drug products for clinical use.
- Salary range: $165-175K/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance