Clinical Operations Manager

Description

Duties

A Clinical Operations Manager focuses primarily on Clinical Operations study execution responsibilities and may take on a limited number of additional functional management and/or departmental infrastructure responsibilities. Alternatively, a Manager may have a dedicated Infrastructure Manager role. As a Lead Study Manager (LSM), a Manager would be the Clinical Operations lead for day-to-day Clinical Operations functional activities associated with the execution of assigned clinical trial(s). Responsible for oversight of Clinical Operations team, Clinical Research Organizations, and third party vendors. Responsible for escalating clinical operations study issues and risks to Study Execution Team Lead. As a dedicated Infrastructure Manager, a Manager will have leadership and/or oversight of sub-teams of the wider Clinical Operations group, such as Clinical Business Operations, eClinical, Resource Capacity Planning, Outsourcing, Training, Quality, Standards, Processes, SOPs and initiatives. May also lead department or cross-functional initiatives. In addition, a Manager that is a LSM or an Infrastructure Manager may be responsible for the management and development of a team of up to 2 direct reports. as a Lead Study Manager (LSM): - Lead all day-to-day Clinical Operations Study activities - start-up, maintenance and close-out - Serve as standing Study Execution Team (SET) member representing Clinical Operations - Approve and maintain study plans - Contribute to detailed SET timeline and execute Clinical Operations responsibilities - Responsible for identifying and escalating issues and risks to the SETL as appropriate - Manage Clinical Operations Clinical Research Organization (CRO) vendor - Oversee the management of specialty vendors including budget(s) and coordinate periodic CRO/vendor project reviews - Oversee Informed Consent Form template development - Review electronic Case Report Form (eCRF) and Clinical Operations user acceptance testing - Execute study quality metrics actions - Accountable for enrollment stimulus strategies - Responsible for the coordination of the data review activities required of the Clinical Operations team member(s); collaborate with Statistical Analysis and Reporting Team (SART) - Manage protocol deviation review - preventative action planning, immediate escalation of significant concerns to Study Execution Team Lead (SETL) and Medical Monitor - Provide clinical supply projections, approve clinical supply demand and IxRS user acceptance testing Responsibilities as a dedicated Infrastructure Manager: - Lead one or more major departmental infrastructure area(s) such as Resourcing, Training or Quality, Standards and Process (QSP) - Manage all elements of the infrastructure area from planning, resourcing, implementation and continuous improvement Additional Responsibilities - Ensure compliance with SOPs and guidelines, FDA regulations and current International Committee of Harmonization - Good Clinical Practices (ICH-GCP) guidelines