Clinical Supply Chain Planner
Proclinical is currently recruiting for a Clinical Supply Planner for a biopharmaceutical company located in Cambridge, MA. Successful candidate will support programs and protocols, in tandem with program leads.
- Interact with internal and external customers and suppliers in order to accomplish project objectives including packaging, labeling, shipment, inventory management, and drug return logistical activities.
- Manage and maintain IMP distribution and return drug plans and manage Clinical Supply documentation associated with assigned program, in compliance with GMP and industry standards.
- Monitor inventory levels and provide feedback to Program leads and their direct Manager regarding expiry and re-supply needs across inventory.
- Participate in clinical supply group's system enhancement initiatives, as assigned and needed.
- Work actively and align with Clinical Operation/Study team to help create forecast for assigned study and program including enrolment rate.
- Support country logistics for shipping and importation, on assigned study or program.
- Monitor regularly drug expiry, and the appropriate inventory levels across assigned clinical programs.
- Support and oversight of packaging requirements for programs and/or protocols assigned
- Monitoring of enrolment, drop-out rates and actual supply need on assigned protocols and/or programs. Ensure continuous re-assessment of Project needs, on assigned programs and/or protocols.
- Lead label creation and approvals process, including translations for all countries, on assigned study and/or program responsible for.
- Supports return and destruction of IMPs from sites to depots for assigned study.
- Interface with other members of the Clinical Supply Chain to provide and obtain information and to ensure on time delivery of assigned study.
- Perform inventory checks and manage inventory levels and cycle count at the vendor yearly on assigned study.
- Manage temperature excursions during transportation on assigned study
Skills and Requirements:
- BS in a scientific field.
- Minimum 0-5 years of relevant experience.
- Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP.
- Must possess exceptional communication skills, self-motivated, exposure and/or knowledge of software programs including Microsoft Project, Power Point, MS Project, Interactive Response Technology (IRT), and Microsoft Office.
- Willingness to learn and sense of urgency to meet patient and program needs. Experience with CGMP and/or CGCP is a plus.
- Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
- Experienced working with third-party CMO clinical supply operations.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.