Senior Clinical Trial Manager

Senior Clinical Trial Manager

Global Clinical Operations

Remote, US

Opportunity

The Senior Clinical Trial Manager will be responsible and accountable for the development of clinical trial operational strategy and leading planning execution of day-to-day study operations, leading the cross-functional Clinical Trial Team (CTT), managing outsourced Contract Research Organization (CRO) and third party vendor activities, and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs).

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.

Qualifications

Minimum of BA/BS degree or equivalent in relevant discipline (scientific background is preferred). Advanced degree is preferred.

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.