Associate Director, Clinical Data Management

Structure Therapeutics•South San Francisco, CA

About The Position

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Reporting to Senior Director of clinical data management (CDM), the Associate Director (AD) will oversee and manage the strategic and operational aspects of data management in support of clinical development activities for assigned studies. The AD is responsible for planning, implementing, and managing CDM CRO activities on assigned clinical studies, including but not limited to database and technology selections, vendor management, data collection, and ensuring quality standards are maintained and all the timelines are met. The AD serves as primary DM contact to collaborate closely with cross-functional teams, including Clinical Operations, Biostatistics, Clinical Development and Regulatory Affairs, to ensure that data management activities align with the overall clinical development strategy and regulatory requirements.

Requirements

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

Responsibilities

Represent the CDM in study meetings, providing updates on ongoing trials, challenges, and strategic direction.
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.
Conducts the regular data reviews to make sure all the key data discrepancies are identified, documented and resolved prior to the deliverables.
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.
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.