This position is responsible for managing clinical trial supply chain for our client's global late stage clinical trials. Responsibilities include clinical packaging/labeling, inventory control, distribution, shipping logistics and all other supply chain activities associated with delivering supplies to clinical sites. Position is responsible for ensuring availability of clinical trial material for timely initiation of trials and maintaining adequate supply at all clinical sites. Incumbent must be experienced in managing clinical trial supply chain and be knowledgeable in global pharmaceutical regulations for clinical trial supply.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Work closely with Clinical Operations, Manufacturing, Quality and Regulatory Affairs to develop clinical supply requirement plans and design of clinical kits and labels
· Select vendors for clinical packaging and labeling
· Manage clinical packaging and labeling at vendors
· Coordinate internal review and approval of clinical labels and packaging records
· Collaborate with Clinical Operations in the development, review and acceptance of IxRS systems
· Perform technical review of clinical packaging batch records
· Work with QA and vendor to release clinical trial material in a timely manner
· Assist QA in deviation investigations and resolving temperature excursions
· Coordinate supply chain activities with vendors, CROs and Clinical Operations
· Manage inventory and forecasting. Alert management in a timely manner if supply replenishment issues are anticipated
· Manage international distribution and logistics for multiple Phase 3 clinical programs
· Manage post-study product reconciliation, returns and destruction
Strong organizational, planning, problem-solving, and decision-making skills.
This position has no supervisory responsibilities.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.
No travel is expected for this position.
Required Education and Experience
- Typically requires a Bachelor's degree in a scientific area with a minimum of 5 to 8 years industry-related experience. At least 3-5 years’ experience in global clinical supply management.
- Good understanding of GMP / GCP, pharmaceutical industry procedures, and regulations.
- Strong understanding of clinical study design, execution, and drug product supply logistics.
- Demonstrated experience in clinical supply chain management including experience managing international clinical trials with multiple drug depots and sites.
- Must be knowledgeable in cold chain logistics management.
- Excellent communication and influencing skills with strong attention to details and a proven ability to collaborate effectively with vendors.
- Able to manage multiple projects effectively and respond promptly to clinical supply issues.
Additional Eligibility Qualifications
- Computer proficiency and technical aptitude with the ability to use Microsoft products.
- Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
- Excellent communication and organization skills.
Equal Employment Opportunity Employer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.