Clinical Trial Operations Manager

Clinical Trial Operations ManagerContract to hire RoleJob Summary:The Clinical Trial Operations Manager will be responsible for overseeing the implementation and execution of clinical trial(s) from start up to close-out. This role involves managing CRO's, study vendors, and clinical trial sites, and collaborating with internal stakeholders to ensure on-time and budgeted completion of clinical trial deliverables in accordance with regulatory requirements, GCP guidelines and internal SOP's.Key Responsibilities:Build and maintain strong working relationships with CRO, investigators, and study staff.Ensure adherence to study protocol, SOPs, and regulations.Support third-party vendor training on protocols and practices.Track and report on study progress including site activation, patient enrollment, and data entry backlogs.Oversee and evaluate performance of CROs and third-party vendors to ensure compliance with study protocol.Contribute to clinical protocols, amendments, informed consent forms, and study-related documents.Participate in quality assurance activities and ensure audit-ready condition of clinical trial documentation.Collaborate with cross-functional teams including Medical Monitor, Regulatory Affairs, and vendors.Manage clinical monitoring activities and ensure compliance with ICH/GCP regulations.Participate in selection, training, and evaluation of study personnel.Qualifications:Undergraduate degree in life sciences or relevant work experience. Graduate degree preferred.Strong therapeutic experience in oncology.Minimum 5 years of clinical trial management experience, with at least 2 years on the sponsor side.Thorough knowledge of clinical research concepts, FDA regulations, and ICH guidelines.Proven experience in early phase clinical trials.Excellent communication skills.