Clinical Operations Manager
10 hours ago
Vanguard Clinical is seeking a highly skilled Clinical Operations Manager to oversee the execution and communication of clinical research studies and operations. The ideal candidate will have a strong background in clinical trial management, with experience in managing both projects and direct reports. This is an exciting opportunity to join a young and lively company in a fast-paced and dynamic environment.
Key Responsibilities- Manage the oversight, implementation, and execution of clinical research studies and operations.
- Ensure the successful conduct of one or more clinical trials, providing oversight and operational planning to ensure all trials are completed on time, within program budget, and to quality standards.
- Directly manage the operations of the trial with internal and/or external cross-functional team members, including global CROs, central laboratories, Central/Local IRBs, data managers, safety reporting, and other vendors.
- Author and/or contribute to the development of study-related documents and plans, in accordance with Vanguard Clinical established standards and procedures and/or Client SOPs.
- Manage external vendors and CROs, including establishing expectations and timelines and clear and ongoing communication.
- Work closely with clinical supply personnel to ensure timely availability of supplies for clinical trials.
- Serve as the primary in-house resource for responding to Investigator and site staff questions regarding eligibility, enrollment, safety concerns, or data quality.
- Minimum of 3 years of related experience at a biotechnology/pharmaceutical company and/or CRO.
- Experience either working at a CRO or overseeing CROs is preferred.
- Experience with all aspects of conducting clinical trials, from initiation through site close-out, prior clinical monitoring experience a plus.
- Strong operational and management skills.
- Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments.
- Must exercise sound judgment and take initiative, be able to work independently with minimal supervision while producing accurate high-quality and timely work.
- Must be able to work effectively within a team environment (independently and collaboratively).
- Excellent written and verbal communication skills, including strong professional presentation skills (internal and external audiences).
- Strong knowledge of the drug development process (domestic and international) is required.
- Knowledge in oncology or rare disease trial execution is a plus.
- Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel, Outlook, etc.).
- Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines.
Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.
Travel RequirementsTravel to San Diego headquarters as needed, if not residing locally.
Compensation and Benefits$110,000 - 150,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)
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