Local Clinical Trial Manager
Posted 2 hours ago
You'll apply on the company's website.
About the Role
In this position, you will serve as a Local Clinical Trial Manager, overseeing operational and quality components for studies of low to moderate complexity. Working within a global, multicultural framework, you will ensure all research activities adhere to ICH GCP standards. You will proactively manage studies by creating monitoring plans and clinical tools while ensuring precise maintenance of trial records. Collaboration with broader clinical teams and project managers will be essential to meeting study timelines, resource needs, and project objectives. You will represent the project during client engagements and bid defenses, maintaining the operational and financial integrity of your work. Furthermore, you will manage study initiation, track performance against contracts, and mentor team members to support a culture of innovation and development.
Requirements
- Hold a Bachelor's degree or an equivalent professional or academic qualification.
- Possess at least five years of related work experience, specifically including an oncology background.
- Demonstrate deep knowledge of clinical monitoring, ICH/GCP standards, and FDA requirements.
- Exhibit strong leadership, interpersonal, and problem-solving abilities with the capacity to make informed decisions in dynamic settings.
- Maintain proficiency in English and advanced skills in Microsoft Word, Excel, and Outlook.
- Provide evidence of expertise in project budgeting, financial management, and forecasting for clinical activities.
- Maintain the capacity and availability to travel both domestically and internationally for site monitoring.
Responsibilities
- Oversee daily clinical operations, including the creation of master action and data quality plans.
- Design informed consent templates and case report forms, while managing Trial Master File setup and archival.
- Lead study start-up tasks, including submissions to regulatory and ethics boards and responding to subsequent queries.
- Monitor project timelines, facilitate communication with clinical sites, manage query resolution, and evaluate site performance.
- Perform field visits, provide regular metrics updates, and execute corrective measures when needed.
- Manage clinical resources and staffing to maintain budgetary compliance and adherence to monitoring protocols.
Benefits & Perks
- Engage with a global team focused on scientific innovation and industry-leading standards.
- Access significant opportunities for professional growth and collaboration.
- Participate in the management of varied, meaningful clinical projects that facilitate continuous career advancement.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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