Job Details

Sr. Manager, CDM

Location: South San Francisco, 3 days onsite

Pay Rate: $90-$100/hr

Duration: 6 months

A leading biotechnology organization is seeking a Contract Senior Manager, Clinical Data Management to oversee data management activities across one or more clinical studies, from initiation through closure. This role ensures timely, high-quality data delivery aligned with project goals and budget. The Senior Manager will report to the Head of Clinical Data Management and collaborate with cross-functional teams in a dynamic, fast-paced environment.

Key Responsibilities

• Lead Electronic Data Capture (EDC) development, including CRF design, specifications, edit checks, and User Acceptance Testing (UAT) documentation.
  
• Review and support development of study documents from CROs, such as data transfer agreements, eCRF Completion Guidelines, and Data Management Plans.
  
• Ensure data quality through rigorous review and reconciliation processes; communicate and resolve outstanding issues.
  
• Collaborate with CROs to develop clean patient trackers.
  
• Coordinate SAS dataset transfers and electronic data exchanges.
  
• Manage rolling and final database lock processes.
  
• Monitor and audit data management deliverables to ensure quality and compliance.
  
• Maintain adherence to regulatory standards (ICH, GCP), internal SOPs, and industry best practices.
  
• Oversee CRO vendor performance to ensure accurate and timely data delivery.
  
• Serve as the primary data management contact for assigned studies.
  
• Participate in team meetings and proactively raise data-related risks and concerns.

• Bachelor's degree in life sciences, computer science, or related field.
  
• 10-12+ years of experience in pharmaceutical or CRO settings, managing Phase I-III studies.
  
• Proficiency in multiple EDC systems within the past 3 years.
  
• Strong expertise in clinical data management processes; certification preferred.
  
• Experience managing external EDC vendors; build experience a plus.
  
• Familiarity with CDISC, CDASH, SAS® terminology, and coding standards (MedDRA, WHODRUG, CTCAE).
  
• Deep understanding of regulatory guidelines and data standards.
  
• Exceptional organizational skills and attention to detail.
  
• Strong communication and interpersonal abilities.
  
• Capable of managing multiple priorities and projects independently.
  
• Comfortable engaging with stakeholders at all organizational levels.
  
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project)