Job Description
Our client is looking to fill the role of Clinical Supply Specialist. The Clinical Supplies Specialist works collaboratively on multi-disciplinary work groups and projects, supporting staff within Clinical Supplies to execute the activities necessary to produce clinical trial study supplies. This role is a great opportunity for someone who thrives working in a task based, agile and global environment. The Clinical Supplies Specialist facilitates the supply and distribution of investigational products (IP) to investigators by interacting with both internal and external customers and suppliers to accomplish project objectives. The Specialist will work with Clinical Supplies Managers to ensure vendors follow distribution and return drug plans, coordinate packaging/labeling, monitor inventory levels and provide feedback to Clinical Supplies Managers regarding expiry and re-supply, if required. This position is hybrid and based out of the Princeton office.
Responsibilities:- Assist in the maintenance and coordination of full drug reconciliation process including review and approval of drug reconciliation records across clinical studies working directly with functional representatives (Clinical, Quality Assurance, etc.) as needed.
- Assist in supply planning and forecasting
- Interpret protocol information to assist in developing packaging/labeling design and distribution strategy
- Assist with coordinating the origination, proofing and translation of clinical study labels as required
- Management of Temperature excursions affecting clinical trial material
- Assist in the review of IP documents, electronic document archiving and quality control
- Track drug supply at the CMO and clinical sites and maintain current inventory records for IP through the life of the trial to avoid supply issues
- Track retest updating of clinical trial material
- Develop templates and SOPs that assist in the management of IP processes
- Assist Clinical supplies team with special projects and study related activities as assigned
- Manage and assist in Clinical Supply meetings
- Maintain close communication with internal study teams to ensure study timelines are met
- Develop a strong working relationship with Quality Assurance for timely review and approval of study documents
Required Qualifications:- Qualified candidates will have a bachelor’s degree
- Minimum 2-3 years of relevant pharmaceutical experience, up to 2 yrs of clinical supplies and IMP management experience with knowledge of clinical trial process.
- Knowledge of Good Manufacturing Practice, Good Clinical Practice and the drug development process
- Strong organizational skills, time management and attention to detail
- Experience with IRT system design, implementation for studies, testing and monitoring.
- Proactive approach to work; identifying potential issues and bringing them immediately to the appropriate team members for resolution.
- Excellent verbal and communication skills
- Ability to influence others
Clinical Resource Network Distinction CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
Job Tags
Hourly pay, Full time, Contract work, Immediate start,