Clinical Trial Operations Specialist
4 weeks ago
Are you a seasoned Clinical Operations Professional looking for a new challenge?
This role offers a unique opportunity to oversee Contract Research Organizations (CROs) and ensure the successful execution of our clinical studies.
We are seeking an experienced professional with technical expertise in managing Phase I-III clinical trials within an industry setting and a solid understanding of clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements.
", "Requirements and Qualifications": "- BS or MS degree; 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably in oncology drug development
- Hands-on experience in running early-stage clinical trials within an industry environment
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience in the selection of CROs and vendors and management of external resources.
- A demonstrable record of strong vendor management and teamwork
- Direct experience in managing clinical CROs
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Excellent written and verbal communication skills
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is crucial.
- Able to travel (~25%)
- Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
- Experience in global clinical trial operations is desirable.
- Knowledge of APAC regulations is highly desired.
Clinical trial, Oncology, drug development, ICH Guidelines, FDA Regulations, GCP, CRO, vendor management, travel, APAC regulations
", "Company Information": "Bayside Solutions, Inc. is an equal opportunity employer.
We are committed to diversity and inclusion in the workplace.
", "Disclaimer": "Bayside Solutions, Inc. may collect your personal information during the position application process.
Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy
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