Manager, Clinical Study Start-Up
New
P
PenumbraClinical research
Your Remote US Home OfficeFull-TimeManager
Salary135,000 - 187,000 USD per year
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Job Details
- Experience
- 7+ years of experience in preclinical research, or the medical devices/pharmaceutical industry, or an equivalent combination of education and experience; 3+ years’ experience in the operational aspects of managing clinical studies from start-up to close-out, vendor management, and planning cross-functional operational activities.
- Required Skills
- Microsoft OfficeTeam management
Requirements
- Bachelor’s degree in Biology, Nursing, Biomedical or Physical Sciences, or a related field, or an equivalent combination of education and experience.
- 7+ years of experience in preclinical research, the medical devices or pharmaceutical industry, or equivalent education and experience.
- 3+ years of experience managing clinical study operations from start-up to close-out.
- Experience in vendor management and planning cross-functional operational activities.
- Knowledge of ICH-GCPs, 21 CFR, and other relevant regulations and standards.
- Experience creating and negotiating clinical budgets and contracts.
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
- Proficiency with Microsoft Office, including Word, Excel, OneNote, and PowerPoint.
- Medical device experience is desirable.
Responsibilities
- Lead the ICRA and CBA teams in study and site start-up, amendment submissions and approvals, site activation, and final site closure.
- Lead or supervise development of start-up materials and study documents, including consent templates, questionnaire licensing, and study manuals.
- Oversee preparation and negotiation of initial clinical trial budgets and budget amendments with clinical study sites.
- Oversee study registration, maintenance, results reporting, and closure in public registries such as ClinicalTrials.gov.
- Update management on start-up progress, communicate delays, and propose actions to support project timelines.
- Establish, monitor, and report start-up performance and quality metrics; drive corrective actions and continuous improvement.
- Guide clinical staff on IRB and Ethics Committee submissions and responses to review comments and requests for information.
- Lead improvements to clinical processes, systems, tools, procedures, SOPs, and work instructions.
- Recruit, hire, supervise, coach, train, and develop ICRA and CBA team members; manage performance and staffing needs.
- Allocate resources across studies, manage project timelines, and coordinate priorities with cross-functional teams.
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