Sr. Manager, Clinical Data Management
Title: Senior Manager, Clinical Data Management Hiring Organization: Connexion Systems & Engineering Compensation, Benefits, and Employment Type • Duration: 6 month contract • Pay rate: $110-$125/hr W2 ONLY. NO THIRD PARTY SUBMISSIONS, NO C2C, NO REFERRALS • Job Location: 100% Remote • Schedule: M-F, flexibility required to accommodate global team members • Job#: bh18341 Description: We are seeking a highly experienced Senior Manager, Clinical Data Management to lead multiple high-volume, complex clinical studies. This role requires deep expertise in Oncology trials, Medidata Rave, and ideally Elluminate. The Senior Manager will provide strategic oversight, hands-on execution, and mentorship while collaborating cross-functionally with internal teams, external vendors, and CRO partners. This is a fully remote position supporting global teams and requires someone who can start immediately. Key Responsibilities • Lead all clinical data management activities across assigned studies with full functional, administrative, and financial oversight. • Identify potential out-of-scope activities early and collaborate on contract modifications while maintaining budget alignment. • Mentor and guide junior staff and study teams to achieve high-quality, compliant deliverables aligned with ICH/Google Cloud Platform. • Proactively identify and resolve operational challenges based on metrics, audit findings, and team input. • Assess risk throughout study lifecycles and implement mitigation strategies. • Execute and oversee clinical data management tasks, including data processing, QC, enrollment tracking, eCRF review, and query management. • Collaborate with CROs, vendors, CDM, and Clinical teams to develop and review CRFs, annotations, and other data collection tools. • Contribute to the creation and refinement of CDM SOPs and Work Instructions. • Review and provide guidance on DMPs, DVS/edit checks, SAE reconciliation plans, and data cleaning strategies. • Partner with CROs to support data cleaning, interim analyses, database lock, and ad hoc requests. • Liaise with external labs and vendors on timelines and deliverables. • Develop data transfer agreements and technical specifications. • Review and validate EDC systems, including screens, edit checks, code lists, UAT outputs, and database structures. • Provide input on protocols, SAPs, and clinical study reports. • Collaborate cross-functionally with Clinical Operations, Research, Medical Monitoring, Medical Writing, and other teams to ensure accuracy and efficiency in data collection. • Apply industry-standard conventions and processes for medical coding. • Oversee study timelines, ensuring milestones and data management standards are met with high quality. • Perform other related duties as needed. Required Qualifications • 10 12 years of experience in Clinical Data Management. • Strong background in Oncology clinical trials. • Extensive experience with Medidata Rave. • Experience with Elluminate preferred. • Proven success overseeing multiple complex studies and mentoring CDM teams. • Strong understanding of ICH/Google Cloud Platform, GxP principles, and global clinical data standards. Apply tot his job