Director, Clinical Operations

Job Description

Job Description

Salary : $208,000 - $254,000

Job Summary

We are seeking a Director, Clinical Operations to provide trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions) for assigned studies. This role ensures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. The Director of Clinical Operations will directly report to the VP of Clinical Operations. The role is a hybrid position requiring 3 or more days on site in our San Diego, CA offices.

Your Responsibilities

• Oversee / monitor Clinical Trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations.
• Safe and timely execution of Clinical Trial from sponsor role.
• Vendor (e.g., CRO, Biometrics, IXRS, PK / Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols / programs. Ensure all Vendor contracts / legal documents current and on file at Alterome.
• Metrics management as identified by Head of Clinical Operations.
• Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
• Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate / required.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping / receipt according to procedure.
• Perform periodic reviews of the CRO eTMF / TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
• Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Meets with vendors to ensure proper vendor oversight.
• Supports financial management of the study which may include review and approval of site and vendor invoices.
• Supports Risk Management initiatives. Proactively alert cross functional team to any risks identified and note suggested risk mitigation to identified risks.
• Supports the filing of legal, team documents in SharePoint working Cross Functionally with Project Management, Clinical, Regulatory and Medical team members.
• Maintain clinical trial registry entry / updates, as required.
• Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors.
• Maintain direct contact and relationships with clinical sites participating in Alterome clinical studies to ensure high-quality and efficient execution of ongoing and planned clinical trial operations.
• Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.
• Performs administrative functions and additional duties as assigned.
• Various activities in support of Clinical, Project Management, Regulatory and Medical team members.

What is Required