Clinical Trial Manager
Description
Job Title : Clinical Study Manager/Clinical Trail Manager Location : Durham, NC 27701 Duration : 12+ Months Pay Rate : $70/HR On W2 (No Benefits) Primary Responsibilities: Provide day-to-day study management support and oversight for assigned clinical study activities from start-up through close-out. Coordinate with internal project team members, CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities. Monitor adherence to essential document collection processes, site activation requirements, clinical supply release requirements, and study-specific tracking tools. Support and/or lead meetings with CROs, vendors, and cross-functional teams to review study progress, risks, issues, action items, and deliverables. Track and support development of study-specific timelines, deliverables, and mitigation plans to address study delays or operational risks. Assist in vendor selection activities, including contribution to RFPs, scopes of work, vendor budgets, and study/vendor-specific planning documents. Evaluate CRO and vendor performance and support early identification, escalation, mitigation, and resolution of potential issues. Develop, implement, and follow up on corrective and preventive action plans, as appropriate. Coordinate and verify study-specific training for CRO staff, vendors, investigators, study coordinators, and other relevant study team members. Support oversight of vendor staff qualification, training, turnover documentation, and ongoing performance against study milestones and KPIs. Required Skills: Strong knowledge of clinical trial operations, study start-up, maintenance, and close-out activities. Strong knowledge of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company SOPs. Demonstrated ability to manage CROs, vendors, study timelines, risks, action items, and cross-functional deliverables. Ability to identify issues, evaluate options, make sound recommendations, and drive timely resolution. Strong verbal, written, organizational, and interpersonal communication skills. Ability to manage competing priorities, work independently, and collaborate effectively with internal and external stakeholders. Experience using clinical systems and tools such as CTMS, eTMF, EDC, Microsoft Office, and study-specific tracking tools. Education and Experience: Bachelor's degree in a life science, health-related, or related field preferred; equivalent directly related experience may be considered. 8+ Years of clinical research experience, including at least two years of experience in clinical study management, clinical operations, or related clinical trial roles. Experience working with CROs, vendors, clinical sites, and cross-functional study teams is required. Experience in sponsor-side study management, vendor oversight, TMF management, audit/inspection readiness, and clinical study documentation is preferred. Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.