Clinical Study Operations Manager
New
B
Beacon BiosignalsLife Sciences
Fully remote anywhere in the U.S.ContractManager
Salary$90,000 – $110,000
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Job Details
- Languages
- English
- Experience
- 5+ years
- Required Skills
- Project ManagementGCPAsanaZendesk
Requirements
- 5+ years of experience in clinical project management or clinical operations roles.
- Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively.
- Excellent written and verbal communication skills in English.
- A proactive mindset with the ability to identify priorities and anticipate challenges.
- Meticulous attention to detail, ensuring accuracy in data collection and reporting.
- Ability to work in a fast paced environment with multiple priorities.
- Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
- Knowledge of decentralized data collection, compliance and oversight while showing empathy for both patients and sites.
- A desire to learn more about analytics, statistics, machine learning, and clinical trials.
Responsibilities
- Collaborate with project teams to implement study startup activities, including communication planning, logistics, development of study documentation, and data configuration.
- Instill confidence with clients on study operations through start up, maintenance and close out activities.
- Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication.
- Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection.
- Monitor project progress, ensuring adherence to timelines, protocols, and quality standards.
- Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards.
- Foster a culture of quality within the ClinOps and Scientific teams by coaching peers on GCP requirements, documentation discipline, versioning, and complaint management.
- Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution.
- Provide actionable feedback from research sites to inform improvements in devices and workflows.
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