Sr. Manager, Clinical Supplies
The Sr. Manager, Clinical Supplies is responsible for operational oversight of the planning, packaging, labeling and distribution of Clinical Trial Materials (CTM) and any additional study medication/products to support clinical trials. He/she is responsible for oversight and management of clinical supply distribution and CMOs and distribution providers. Ensures operations and activities are executed in accordance with all internal SOPs and in accordance with all county, state, and federal regulations including GMP regulations and internal ICH guidelines.
The incumbent works cross-functionally with internal departments and external resources on Clinical Supply related issues.
location: Pennington, New Jersey
job type: Contract
salary: $45 - 55 per hour
work hours: 9 to 5
- Reviews clinical protocol and provides input to CTM section.
- Recommends packaging requirements based on an understanding of the technical aspects of the packaging to provide patient friendly packages that support site dispensing approaches.
- Designs packaging, labeling, and subsequent assembly plans for CTM, comparators and ancillary supplies.
- Ensures appropriate lead times are planned for the ordering and packaging of clinical trial supplies by monitoring recruitment rates and actual supply needs; ensures continuous re-assessment of supply needs as recruitment and the study progresses by monitoring the use of adequately dated clinical trial supplies at each investigational site.
- Manages and directs clinical trial supplies return process of vendor by ensuring the reconciliation of CTM and documentation of destruction.
- Participates in clinical study team meetings; advises the study team on the optimal supply strategy, aligns with study details and collaborates in achieving study objectives by providing supporting information to the study teams as required; communicates and discusses clinical trial supply timelines, cost and risk limitations.
- Manages the storage, distribution and inventory tracking of bright stock, labeled product, and ancillary inventory throughout the clinical supply chain at CMOs in the most cost effective manner and in compliance with GMP requirements.
- Schedules and implements labeling, packaging and quality release operations with CMOs and internally with Quality department to ensure continuous clinical supply.
- Coordinates GMP auditing activities at CMOs; provides management with accurate time frames for resolution of delays in obtaining supplies for clinical projects; recommends insight and ideas into procedural improvements as needed and assist in the implementation of the improvements.
- Creates label design and coordinates approvals, including obtaining language translations for all participating countries and the associated Health Authority regulatory requirements; obtains cross functional approvals on the labels within the company and the CRO country representatives as required.
- Performs other tasks and assignments as needed and specified by management.
- Bachelor's degree and a minimum of 6 years relevant clinical drug supplies experience in a pharmaceutical, biotechnology, contract research organization (CRO), university medical center or related environment.
- Hands-on experience supporting and understanding GMP, GCP, and ICH guidelines as related to CTM labeling, packaging and distribution operations and the overall drug development process.
- Hands-on experience supporting clinical supply chain for clinical trials.
- Proficiency with Microsoft Office (including MS Project).
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
skills: Clinical Supply Chain, Clinical Trial Supply Strategy, Import/Export
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.