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Clinical Supplies Manager
2 months ago
Position Overview:
Our client is seeking to hire a Clinical Supply Coordinator. This role is essential in collaborating with cross-functional teams and projects, aiding the Clinical Supplies department in executing the necessary tasks to produce supplies for clinical trials. This position is ideal for individuals who excel in a dynamic, task-oriented, and global setting.
Key Responsibilities:
- Support the comprehensive drug reconciliation process, including the review and approval of reconciliation records across various clinical studies, working closely with functional representatives such as Clinical and Quality Assurance.
- Assist in the planning and forecasting of supply needs.
- Analyze protocol details to aid in the development of packaging, labeling designs, and distribution strategies.
- Coordinate the creation, proofing, and translation of clinical study labels as necessary.
- Manage temperature excursions that impact clinical trial materials.
- Review investigational product documents, oversee electronic document archiving, and ensure quality control.
- Monitor drug supply at Contract Manufacturing Organizations (CMOs) and clinical sites, maintaining accurate inventory records throughout the trial to prevent supply disruptions.
- Track updates for retesting of clinical trial materials.
- Create templates and Standard Operating Procedures (SOPs) to enhance the management of investigational product processes.
- Assist the Clinical Supplies team with special projects and study-related tasks as assigned.
- Facilitate Clinical Supply meetings and maintain effective communication with internal study teams to ensure adherence to study timelines.
- Develop a robust working relationship with Quality Assurance for timely review and approval of study documentation.
Qualifications:
- A bachelor's degree is required.
- 2-3 years of relevant experience in the pharmaceutical industry, including up to 2 years in clinical supplies and Investigational Medicinal Product (IMP) management, with a solid understanding of the clinical trial process.
- Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and the drug development lifecycle.
- Exceptional organizational skills, time management abilities, and attention to detail.
- Experience with Interactive Response Technology (IRT) system design, implementation, testing, and monitoring.
- A proactive work approach, identifying potential challenges and promptly addressing them with the appropriate team members.
- Strong verbal and written communication skills.
- Ability to influence and collaborate with others effectively.
About Clinical Resource Network (CRN):
CRN, a division of Solomon Page, is dedicated to providing comprehensive clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Established in 2002, we focus on building long-term relationships, offering services that include contract staffing, project staffing, consultative services, and full-time placements.
Join us in making a difference in the clinical research landscape.
