Overview
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Clinical Data Management (Contract) based
Full job description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Clinical Data Management (Contract) based in the United States. The Manager, Clinical Data Management is responsible for overseeing data management activities across clinical and pharmaceutical trials at multiple phases. You will ensure clinical data is collected, managed, and reported accurately, securely, and in accordance with applicable standards. The role serves as a key connection point between Data Management, Clinical Operations, Medical, Biostatistics, Quality, Regulatory, Project Management, and external vendors. You will oversee CRO relationships, manage study deliverables, and address data management risks and issues throughout the study lifecycle. The position offers an opportunity to contribute to complex clinical programs and help maintain high-quality data supporting oncology drug development. Success requires strong organization, communication, technical expertise, and the ability to operate independently in a fast-paced environment.
Serve as the primary Data Management contact for assigned clinical studies, collaborating with Clinical Operations, Medical, Project Management, Biostatistics, Quality Assurance, Regulatory Affairs, and external vendors. Manage CROs and Data Management vendors, including priorities, project plans, scopes, timelines, deliverables, and changes throughout the study lifecycle. Act as a Data Management Subject Matter Expert from protocol review through database lock and study closeout. Develop and execute Data Management project plans covering timelines, milestones, quality control, database setup, study conduct, and closeout activities. Oversee the quality and timeliness of vendor deliverables and ensure work meets established Data Management standards and requirements. Monitor vendor performance, identify risks or issues, and escalate concerns to vendor management and senior leadership when appropriate. Communicate project status, quality metrics, timelines, and vendor performance to relevant stakeholders and develop mitigation or action plans as needed. Participate in the review of protocols and other study documentation to ensure Data Management requirements are appropriately addressed. Ensure applicable Data Management standards, procedures, and SOPs are consistently followed across assigned studies. Manage complex clinical trials and cross-functional partnerships while providing Data Management expertise on special initiatives. Identify and resolve data management challenges proactively while maintaining accountability for study milestones and deliverables. Requirements: Bachelor’s or master’s degree and 4–8+ years of experience in Clinical Data Management or a related Data Management discipline. Demonstrated experience managing CROs and Data Management vendors, preferably within global or cross-cultural environments. Strong understanding of the drug development lifecycle and clinical data management processes. Knowledge of pharmaceutical industry guidelines, best practices, Good Clinical Practice (GCP), 21 CFR requirements, and other applicable global regulatory standards. Familiarity with Electronic Data Capture (EDC) systems and general proficiency with Microsoft Word, Excel, and Project. Knowledge of clinical data coding and related data management practices. Excellent written, verbal, and presentation skills, with the ability to communicate effectively across technical and functional teams. Proven ability to manage multiple studies, processes, and competing priorities under tight timelines. Strong relationship-building and stakeholder management skills, with the ability to manage expectations across CROs and multidisciplinary clinical teams. Demonstrated ability to influence stakeholders, build trust, resolve conflicts, and create shared goals across internal and external teams. Strong negotiation, analytical, and problem-solving capabilities, with a proactive approach to identifying and addressing issues. Highly detail-oriented, accountable, and organized, with the ability to maintain quality across complex deliverables. Comfortable working independently with minimal supervision in a fast-paced environment. Oncology clinical study experience is a plus. Benefits: Contract position based in the United States. Hourly compensation of $50–$80. Opportunity to contribute to clinical and pharmaceutical trials across multiple development phases. Exposure to cross-functional collaboration spanning Clinical Operations, Medical, Biostatistics, Quality Assurance, Regulatory Affairs, and Project Management. Opportunity to work on complex clinical programs within an oncology-focused environment.
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