Senior Manager, Clinical Data Management, Study Lead

📋 Description

• Serve as the clinical data management study lead and primary point of contact for clinical study
• Oversee clinical data management activities throughout the study lifecycle, from start-up and
• Provide sponsor oversight of CRO data management activities, evaluating deliverables, identifying
• Review and approve essential study documentation, including data management plans, case report form
• Ensure study documentation remains inspection-ready and that electronic Trial Master File (eTMF)
• Monitor data quality, project timelines, deliverables, and operational risks, proactively

🎯 Requirements

• Bachelor's degree in Mathematics, Science, or a related field.
• At least eight years of clinical data management experience within the biotechnology
• Demonstrated experience leading clinical studies and study teams in a data processing or clinical
• Strong knowledge of applicable regulatory requirements and industry standards, including 21 CFR
• Experience overseeing CROs and external data vendors, reviewing study documentation, monitoring
• Strong understanding of clinical data management processes across the study lifecycle, including

🎁 Benefits

• Annual salary range: $134,400–$219,200, with final compensation determined by factors such as role
• Competitive total rewards package, which may include annual bonuses or other incentive plans and
• Retirement benefits, including a 401(k) plan with company matching, where applicable.
• Health and wellness programs.
• Medical, dental, and vision insurance, as well as life and disability insurance, depending on
• Paid time off and family support benefits.