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.