Senior Clinical Trial Manager

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.

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.

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

Pay

Base Salary Range of $192,000 to $206,000 plus bonus and long term incentives.