Senior Clinical Trial Manager/Lead

Reporting to the Clinical Program Lead, this role will be responsible to independently lead and oversee one or more global clinical trials and to deliver study outcomes within schedule, budget, quality/compliance and performance standards.

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.

Qualifications

• BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience preferred.
• 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.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range: $150,000-$220,000, commensurate with level and experience