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Clinical Trial Manager
| Company | Retro Biosciences |
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| Location | San Carlos, CA, USA |
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| Salary | $140000 – $175000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field with 5+ years of clinical trial management experience in a Pharmaceutical/Biotech organization.
- Experience in managing CROs, clinical sites, and cross-functional study teams.
- Proven, excellent project management, organizational, and communication skills.
- Strong knowledge of ICH-GCP guidelines, and regulatory requirements, clinical trial phases, especially early Phases.
- Experience with clinical trials for small molecule products in an industry environment.
- Flexibility to work adjusted schedules to accommodate international time zones, ensuring effective management of vendors and partners.
- Strong leadership and problem-solving skills, proactively identifying risks and implementing solutions.
- Experience managing multiple priorities and diverse teams and stakeholders to meet deadlines in a fast-paced environment.
- Strong attention to detail with a focus on data integrity and quality assurance.
Responsibilities
- Support and collaborate with cross-functional teams to plan, initiate, and oversee clinical trials, ensuring alignment with company timelines and objectives.
- Identify, engage, and manage the activities of clinical CROs, central lab, imaging, and specialty labs to execute clinical trials.
- Support site specific development of IRB submission packages or central IRB submissions.
- Obtain and review all required essential documents necessary for study/site initiation.
- Contribute to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.
- Monitor CRO and site performance, including recruitment, data collection, and compliance.
- Ensure trial logistics, such as drug supply and data collection, are managed efficiently.
- Provide support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable.
- Monitor trial data quality, integrity, and completeness. Prepare and deliver trial progress updates to senior management and stakeholders.
- Ensure all trial activities comply with regulatory standards and guidelines (e.g., GCP, FDA, EMA, TGA).
Preferred Qualifications
- Experience coordinating international trials.
- Experience in neurodegenerative diseases or Alzheimer’s Disease clinical trials.
