Oversee clinical study operations, ensure compliance with GCP, manage project timelines, budgets, and team communication while mentoring team members.
ESSENTIAL DUTIES
- Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection
- Facilitate and foster positive, productive, and timely communication between Sponsor, study team, and other functional groups
- Manage and motivate study team while serving as a mentor. Mentorship may include identifying skills of the clinical team members and assisting with further professional development
- Provide proper financial oversight of study budget, including out of scope tracking
- Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals (Project Review)
- Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e. monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)
- Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans
- Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project
- Actively manage and track study risks (with team and Sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issues
- Assess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans
- Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their role
- Monitor and manage the project’s progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as needed
- Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsor
OTHER QUALIFICATIONS
- Outstanding interpersonal, oral, and written communication skills
- Proven effectiveness as a team leader
- Prior experience successfully managing multifaceted studies from inception through implementation and completion
- Outstanding organizational and time management skills
- Experience managing projects in a virtual environment
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
Requirements
RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience
Benefits
- Competitive pay
- Career growth
- Full medical, dental, and vision benefit packages
- 401(k)
- Commuter benefits
- Legal benefits
- The best coworkers, if we do say so ourselves
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