Note: The job is a remote job and is open to candidates in USA. Menarini Stemline is hiring a Senior Clinical Trial Manager to develop clinical trial operational strategy and lead day-to-day study operations. The role leads cross-functional trial teams, manages CRO and vendor activities, and oversees timelines, budgets, quality, and regulatory compliance.

Responsibilities

• Manages 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
• Designs or assists in the 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
• Contributes to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); manages interface with CROs in cooperation with line functions; ensures vendors meet quality standards in their work for the trial; contributes to the development/amendment of vendor contracts
• Acts as initial point of contact for all site-related issues and procedural questions
• Core member of the global cross-functional Clinical Trial Team (CTT); reports study progress and issues/resolution plan at the CTT meeting; writes CTT meeting minutes. Organizes and chairs trial sub teams within the scope of his/her delegated responsibilities
• Defines the Data Review Plan; ensure clinical trial data is cleaned to ensure scientific excellence
• Manages study-specific vendors, as appropriate
• Supports the Clinical Trial Lead/Program Lead with the development, management and tracking of the trial level budget including forecast, and annual budget reviews
• Organization and logistics of various 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) is maintained appropriately throughout the trial, including periodic reviews
• Contributes to operational excellence through process improvement and knowledge sharing
• Participates and support response to Quality Assurance and/or regulatory authority inspection audits
• Ability to collaborate with other departments to meet study timelines and goals
• Provides guidance and mentorship to Clinical Trial Managers and Clinical Trial Assistants
• Supports departmental functions and attends departmental meetings

Skills

• Minimum of BA/BS degree or equivalent in relevant discipline
• Minimum of 8 years of experience in clinical research with a sponsor company or CRO
• Oncology experience is required
• 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
• Ability to manage various activities associated with multiple clinical studies in accordance with designated project assignments
• Understanding of basic biological principles in oncology required
• Excellent knowledge on ICH/GCP, FDA-CFR
• Able to communicate effectively
• (scientific background is preferred)
• Advanced degree is preferred

Benefits

• Bonus and long-term incentive programs
• Fidelity 401(k) with company match
• Anthem Premier PPO and HDHP insurance plans
• Company-paid Basic Life & AD&D insurance
• Pre-tax FSA/HSA programs
• Remote, US

Company Overview

Company H1B Sponsorship