1-617-500-6690 [email protected]
  • Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: Clinical Trial Leader

Job Number: 31823

Location: Remote, 

Job Description

Clinical Trial Lead will be responsible for applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, investigational product and client.

This role is fully remote, based anywhere in the US.

Responsibilities

– Manage clinical operations deliverables including timeline, quality, scope, and financials
– Work closely with the Project Manager to develop plans, monitor resource allocation and ensure that clinical site management and monitoring is being delivered per contract with quality and efficiency
– Proactively identify risks and escalate to Project Manager and other appropriate functional leads
– Together with the Project Manager, ensure transparent communication both internally and externally regarding study progress and issues
– Develop and maintain project-specific clinical operations plans as required per project (e.g. Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan, etc.)
– Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs
– Develop training materials and conduct training for the clinical operations team throughout the project lifecycle
– Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency, and quality
– Manage CRA resourcing, site assignments, visit schedules and serve as the initial point of contact for clinical operations and monitoring issues
– Review and approve site monitoring visit reports; monitor and track related metrics for compliance with Clinical Monitoring Plan and Highline SOPs
– Conduct monitoring visits, co-monitoring visits, assessment visits, and/or team training as necessary

Required Skills

– Minimum of 7 years of relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
– Minimum of three (3) year experience as a Clinical Trial Lead or equivalent (Clinical Trial/Study Manager) or relevant clinical operations experience at a CRO, biotech, or pharma company
– Ideally, experience in Ophthalmology
– In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
– Early phase clinical trial experience

 

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