Job Description
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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 Job Location:
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/GCP. 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/GCP, GxP principles, and global clinical data standards. Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly. You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line. If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com . We would be glad to help you find the perfect job!
