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gcp project management microsoft office clinical trials ichπ Description
- Plan, implement, and drive biosample logistics for Phase I-IV trials.
- Advise on biosample strategy respecting quality, ethics, and regulatory standards.
- Standardize biosample activities across trials; oversee collection, processing, and storage.
- Review protocols, informed consents, and lab documents for sample handling.
- Plan and coordinate lifecycle of patient samples from collection to disposition.
- Track biosample status, address issues, and drive resolutions.
π― Requirements
- Bachelor's degree in science/healthcare field, a nursing degree, or equivalent.
- 4-6 years of clinical trial management experience preferred.
- 2+ years of hands-on clinical biosample project management experience.
- Understanding of the drug development process to manage cross-functional teams.
- Proven ability to build relationships with external partners, CROs, and biosample vendors.
- In-depth knowledge of GCP and ICH guidelines.
π Benefits
- Career advancement and development opportunities
- Competitive compensation package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
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