Clinical Operations Specialist 1
MILLENNIUMSOFT
Roles & Responsibilities
- Collaborate with Clinical Study teams, Medical Affairs, and cross-functional stakeholders
- Support procurement and sourcing of study products, supplies, and vendors
- Develop and execute secondary labeling and packaging for clinical study products
- Inspect study products for compliance with SOPs and study requirements
- Manage study product and supply inventory using inventory management databases
- Assemble study kits, perform labeling, over-labeling, and documentation
- Ensure proper storage of study products under controlled temperature and humidity conditions
- Coordinate domestic and international packaging and shipping documentation
- Track shipments and maintain records in eTMF
- Manage return, reconciliation, and disposition of study products at study close
- Support transparency reporting for assigned studies
- Minimum 3 years of experience in clinical operations, medical device, pharma, or biotech
- Hands-on experience with clinical study supply management, labeling, packaging, and inventory
- Experience working in a regulated clinical research environment
- Knowledge of Good Clinical Practice (GCP) and clinical trial regulations
- Strong inventory management and documentation skills
- Proficiency in MS Word, Excel (formulas), and databases
- Strong written and verbal communication skills
- Highly organized, detail-oriented, and process-driven
- Ability to work effectively in a matrix and cross-functional environment
- Comfortable handling physical tasks such as kitting and labeling
- Bachelor's degree in Science, Engineering, Pharmacy, or related field
- Database experience is mandatory
- Ability to lift up to 30 lbs and perform repetitive labeling/kitting tasks
Vacancy posted 8 hours ago
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