Manager, Clinical Data Management Study Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise lead Data Managers on designated clinical data management studies.

• Act as the DM study lead and primary liaison for clinical study teams, external data vendors, and CROs.

• Oversee data management tasks from the initiation of the study through to archiving.

• Offer data management expertise and practical support concerning eCRF and database design, data quality, and reporting.

• Supervise data quality assessments and acceptance procedures prior to data analyses and/or database lock.

• Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding.

• Assist with study database transfer, locking, and archiving processes.

• Coordinate scheduling and manage time constraints across various projects.

• Prepare suggestions for enhancing data management processes and data flow.

• Oversee CRO data management tasks and ensure compliance with SOPs and WIs regarding eCRF, clinical trial databases, and electronic edit checks.

• Identify gaps in data quality, CRO performance, documentation, and process execution, ensuring they are addressed.

• Document sponsor oversight from protocol review to study closure.

• Review and authorize study documentation.

• Conduct quality reviews and inspection readiness activities for quarterly IRR compliance.

• Lead and manage data management deliverables, timelines, snapshot/lock plans, status metrics, and program-level contributions.

• Monitor data quality and oversee the resolution of data issues.

• Identify potential risks, suggest mitigations, and proactively escalate operational, vendor, or CRO concerns.

• Provide limited program-level support for smaller programs.

⛳️ Requirements

• Bachelor’s Degree or equivalent experience in Mathematics, Science, or a related field.

• Minimum of 7 years of clinical data management experience in the biotechnology, pharmaceutical, or health-related sectors.

• In-depth expertise in clinical data management.

• Familiarity with eCRF and database design, data quality, and database/data quality status reporting.

• Experience in data quality reviews and acceptance before data analyses and/or database lock.

• Proficient in managing data transfers with CROs and third-party data sources.

• Knowledgeable in SAE/AE reconciliation and MedDRA/WHO-DD coding.

• Experience with clinical trial databases and electronic edit checks.

• Background in quality review and inspection readiness.

• Ability to create deliverable timelines, snapshot/lock plans, metrics, and status updates.

• Capability to monitor data quality, resolve data issues, identify risks, propose mitigations, and escalate operational or vendor/CRO concerns.

• Willingness to travel up to 25%.

🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness initiatives.

• Fitness center access.

• Medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support programs.

• Reasonable accommodation during the recruitment process when necessary.