The Clinical Trial Manager (CTM) is accountable for ensuring high-quality deliverables are within timelines and budget. This position will work closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. For this study, the role is that of a Lead Study Manager.
Responsibilities:
Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc. for assigned region(s) or study(s)
Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc.
Lead, or actively contribute to, Study Management Team meetings
Identify study risks, develop and implement mitigation strategies
Oversee Trial Master File, Completeness Reviews, and Essential Document List
Support the study budgeting process, including the review of invoices and clinical trial financial accruals
Serve as a subject matter expert on initiatives and working groups
Mentors Clinical Operations Staff (Clinical Trial Associates, Specialists, CTMs), including onboarding of new hires
Requirements / Qualifications:
Bachelors degree or equivalent is required (scientific or healthcare discipline preferred)
Typically 6 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred
Fully proficient in the management and execution of clinical trials 4.
Excellent planning, organizational, and communication skills
Able to handle multiple tasks and deadlines; and identify risks and issues and take appropriate actions
Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter organizational impact
Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites
10% travel may be required
Numbers & Facts
Location
Remote, CA (Remote)
Skills
Billingunmatched
Budgetingunmatched
Case Report Form (CRF)unmatched
Clinical Researchunmatched
Clinical Trialunmatched
Clinical Trial Managementunmatched
Communication Skillsunmatched
Contract Research Organization (CRO)unmatched
Cross-Functionalunmatched
Forecastingunmatched
Healthcareunmatched
Identify Issuesunmatched
Informed Consentunmatched
Mentoringunmatched
Multitaskingunmatched
Onboardingunmatched
Operations Managementunmatched
Organizational Skillsunmatched
Problem Solving Skillsunmatched
Purchase Ordersunmatched
Regulationsunmatched
Reporting Dashboardsunmatched
Risk Analysisunmatched
Risk Managementunmatched
Standard Operating Procedures (SOP)unmatched
Startupunmatched
Time Managementunmatched
Vendor/Supplier Managementunmatched
Vendor/Supplier Planningunmatched
Willing to Travelunmatched
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