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Clinical Study Operations Manager
Beacon Biosignals. Ensure successful operational delivery of Beacon’s clinical studies from startup through close-out .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical project management, ensuring compliance with GCP and ICH guidelines while effectively overseeing study startup and operational delivery. Strong communication and organizational skills are essential for managing multiple priorities and collaborating with stakeholders.
Highest-signal resume keywords
Clinical Project ManagementGCP ComplianceICH Guidelines FamiliarityOperational OversightStakeholder Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsData CollectionStudy DocumentationProject ManagementRisk IdentificationTraining DevelopmentQuality Standards MonitoringDecentralized Data CollectionComplaint ManagementVersioning Discipline
Soft Skills
Organizational SkillsAttention to DetailProactive MindsetEffective CommunicationEmpathy
Tools & Technologies
ZendeskAsana
Industry Keywords
Clinical StudiesRegulatory StandardsStudy Startup ActivitiesSite OnboardingClinical Research
About the role
Key responsibilities & impact- Ensure successful operational delivery of Beacon’s clinical studies from startup through close-out
- Collaborate with project teams on study startup activities, including communication planning, logistics, study documentation, and data configuration
- Oversee study startup planning, site onboarding and training, and ongoing operational oversight
- Act as the primary point of contact for clinical sites
- Provide training to research sites on Beacon’s devices and study protocols
- Monitor project progress and adherence to timelines, protocols, and quality standards
- Maintain compliance with GCP, ICH guidelines, and regulatory standards
- Coach peers on GCP requirements, documentation discipline, versioning, and complaint management
- Address operational issues and escalate through tools such as Zendesk and Asana
- Provide feedback from research sites to improve devices and workflows
- Work with sponsors, project teams, and clinical sites to identify risks and maintain stakeholder alignment
Requirements
What you’ll need- 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; additional languages are a bonus
- 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
Benefits
Comp & perks- Equity
- PTO
- Asynchronous work practices
- Fully remote work
- In-person office hubs available in Boston, New York, and Paris
- Up to 10% travel