OverviewClinical Trial Lead Remote US Opportunity Lead the planning, execution and oversight of designated clinical studies, from initiation through study closure. Ensure compliance with quality standards, regulatory requirements, timelines, and budget commitments.
ResponsibilitiesMain Tasks - Independent development of study related documents including but not limited to protocol, 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.
- Serves as main study contact for the cross functional team, CROs, vendors (as applicable) and acts 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 meetings.
- Key contributor to the Data Review Plan; manages data flow and data cleaning process.
- Key contributor to the TMF Plan.
- Manages study-specific vendors, as appropriate.
- Supports the Clinical Program Lead with the development, management and tracking of the trial level budget(s) including approving invoices, 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).
- Responsible for the maintenance of the electronic Trial Master File (eTMF) throughout the trial, including oversight and participation of 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 and always maintains inspection readiness.
- 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 departmental functions and attends departmental meetings.
Qualifications and Education Requirements - BA/BS or equivalent degree in relevant discipline (scientific or health-related background is preferred).
- Minimum of 4-6 (CTL) and 7-10 years (Sr. CTL) of experience in clinical research with a sponsor company or CRO (oncology/hematology experience required).
- Advanced understanding of clinical development within one or more Phases of trials (Phase I, II, and III).
- Scientific learning agility to quickly develop a sound working knowledge of the therapeutic area.
- Able to independently manage various activities associated with multiple clinical studies in accordance with designated project assignments.
- Excellent knowledge on ICH/GCP, FDA-CFR.
- Able to communicate effectively.
Base Salary range: $218,286-$250,000. Menarini Stemline offers generous compensation and benefits packages, including Short and Long-Term Incentive Programs, Fidelity 401(k) (with 6% company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.
QualificationsQualifications and Education Requirements - BA/BS or equivalent degree in relevant discipline (scientific or health-related background is preferred).
- Minimum of 4-6 (CTL) and 7-10 years (Sr. CTL) of experience in clinical research with a sponsor company or CRO (oncology/hematology experience required).
- Advanced understanding of clinical development within one or more Phases of trials (Phase I, II, and III).
- Scientific learning agility to quickly develop a sound working knowledge of the therapeutic area.
- Able to independently manage various activities associated with multiple clinical studies in accordance with designated project assignments.
- Excellent knowledge on ICH/GCP, FDA-CFR.
- Able to communicate effectively.
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: $218,286-$250,000. Menarini Stemline offers generous compensation and benefits packages, including Short and Long-Term Incentive Programs, Fidelity 401(k) (with 6% company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.
