Director, Clinical Data Management jobs in United States
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Structure Therapeutics · 19 hours ago

Director, Clinical Data Management

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The Director of Clinical Data Management will coordinate with CDM partner CRO to set up a pivotal AI-enabled system and lead data managers in managing CDM CRO activities for clinical programs and studies.

BiotechnologyHealth CareMedicalPharmaceuticalProduct Research

Responsibilities

Ensure the oversight activities are conducted by the internal study teams as specified in the study specific Data Quality Oversight Plan (DQOP), and the observations are documented on the study specific cumulative Data Issue Tracker, and the confirmation of resolution are properly documented
Coordinate with CDM partner CRO to set up the pivotal AI enabled system to facilitate the automated data review and cleaning
Represent the CDM in program and study meetings, providing updates on ongoing trials, challenges, and strategic direction
Assist the head of data management in establishing standards for electronic Case Report Forms (eCRFs), edit checks, data listings and reports, and data metrics, and identifying opportunities for process improvements and leading initiatives to enhance the efficiency and effectiveness of data management activities
Supervise the development, validation, and production release of all clinical databases in accordance with both Structure and CRO SOPs and working instructions, and in line with Structure global standard library, oversee and conduct sponsor acceptance testing
Contribute to the development/review of all the DM documentations, including but not limited to CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, Data Transfer Specifications, etc
Support and lead the development of SOPs, procedural documentation and continuous process improvement activities. Identify areas for simplification and innovation as well as new and emerging enabling technologies

Qualification

Clinical Data ManagementMedidata PlatformPharmaceutical DevelopmentData Quality OversightProcess ImprovementLife Sciences DegreeInformaticsComputer SciencesVendor ManagementSoft Skills

Required

BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields
10+ years of clinical data management experience in pharmaceutical and/or CRO's
Complex and international trial experience desired
Extensive experience with different modules on Medidata Platform

Benefits

Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical, dental, and vision insurance
401k match
Unlimited PTO
A number of paid holidays including winter shutdown

Company

Structure Therapeutics

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Structure Therapeutics specializes in the discovery and development of drugs against a type of targets called GPCR.

Funding

Current Stage
Public Company
Total Funding
$1.77B
Key Investors
Biotechnology Value FundQiming Venture Partners
2025-12-09Post Ipo Equity· $747.5M
2024-06-05Post Ipo Equity· $547.4M
2023-09-29Post Ipo Equity· $300M

Leadership Team

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Raymond Stevens
Chief Executive Officer
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Jun Yoon
Chief Financial Officer
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Company data provided by crunchbase