About this role
Role Overview
- lead and develop a team of Clinical Laboratory Study managers (CLSM)
- build lab database to address clinical trial sample collection needs, kits, testing and logistics
- Monitor's acquisition of clinical trial samples and ensure compliance with ICF permissions
- Support individual clinical study teams for all sample-related matters
- Work closely with central lab and/or specialty lab project managers
- Oversee Study start up, closeout and overall life-cycle activities for assigned studies
- Provide input on sample-related section in clinical trial-related documents
- Enable transfer of sample/testing data from vendors through development and review of appropriate data transfer specification
Requirements
- A Bachelor's degree
- minimum of 8 years of pharmaceutical experience in matrix interaction
- preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams
- Minimum of 5 years' experience with Clinical Trials, focus on clinical sample collection
- Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested
- Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits