Menarini Stemline · 6 hours ago
Clinical Trial Manager/Lead
United States
Contract
Remote
Senior Level, Lead/Staff
$150K/yr - $220K/yr
10+ years expMenarini Stemline is an Italian pharmaceutical company with a strong commitment to oncology and a rich history since 1886. The Clinical Trial Manager/Lead will independently oversee global clinical trials, ensuring they are delivered on schedule, within budget, and meet quality standards while managing relationships with vendors and contributing to operational excellence.
BiotechnologyHealth CareHealth DiagnosticsOncology
Responsibilities
Independent development of study related documents including but not limited to: protocol, case report forms, case report form completion guidelines, study manuals, project tools, project plans, tracking tools, and informed consent forms templates
Develops clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with line functions; ensuring vendors meet quality standards in their work for the trial; contributing to the development/amendment of vendor contracts
Oversees efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operation staff and departments as appropriate
Leads study management team meetings and teleconferences
Acting as point of contact for escalation of issues and creation of mitigation plans
Chair of the global cross-functional Clinical Trial Team (CTT), develop agenda and run meeting
Key contributor to the Data Review Plan; manages data flow and data cleaning process
Manages study-specific vendors, as appropriate
Supports the Clinical Program Lead with the development, management and tracking of the trial level budget(s) including forecast, and annual budget reviews
Develops materials for trial advisory committees (e.g. Data Monitoring Committee, Steering Committee)
Manages relationships to ensure successful delivery of all study lifecycle deliverables (RFP through completion of the trial)
Ensures that the electronic Trial Master File (eTMF) maintained appropriately throughout the trial, including periodic reviews
Contributes to operational excellence through process improvement and knowledge sharing
Participates and responds to Quality Assurance and/or regulatory authority inspection audits, responsible for identifying and implementing corrective action and risk mitigation
Ability to collaborate with other departments to meet study timelines and goals
May serve as line manager to one or more Clinical Trial Assistants. Provides guidance and mentorship to the Clinical Trial Manager and Clinical Trial Assistant
Supports of departmental functions and attends departmental meetings
Qualification
Required
BS/BA degree in a scientific or health related discipline
Minimum of 10 years experience in drug development, clinical research and operational strategy including responsibility for ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred)
Small biotechnology company experience a plus
Demonstrated project/program management skills including risk assessment, timeline and budget management and contingency planning
Line management experience including talent identification, development, coaching, performance management and resource allocation
Effective team leadership of matrix teams
Excellent communication, management and organizational skills, problem-solving, conflict resolution, and team building skills
Experience across several complex therapeutic areas
Experience planning and delivering US-based and global clinical programs and studies
Multi-study experience managing early through late-stage clinical trials
Working knowledge of, and experience with, clinical trial conduct, GCPs and FDA Regulations
Preferred
Advanced scientific or equivalent experience preferred
Company
Menarini Stemline
The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc.
501-1000 employees
H1B Sponsorship
Menarini Stemline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (2)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$195.09MKey Investors
Pequot Capital
2020-05-04Acquired
2019-08-01Post Ipo Equity· $88M
2019-01-15Post Ipo Equity· $92M
Leadership Team
David Gionco
Vice President of Finance and Chief Accounting Officer
Ahmed Rabie
Chief Commercial Officer
Recent News
2025-10-13
2025-09-27
Company data provided by crunchbase