Job description
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.
Qualifications
- 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)