Senior Manager, Clinical Data Management

Structure Therapeutics•South San Francisco, CA

15h

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. Position Summary: Reporting to the Director, Clinical Data Management (CDM), Senior Manager (SM) will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeline of clinical data across multiple Phase I studies. SM will provide strategic oversight and direction to CRO CDM team for assigned studies. The SM 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.
8+ years of clinical data management experience in pharmaceutical, biotech and/or CRO’s
Extensive experience with different modules on Medidata Platform

Responsibilities

Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.
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.
Represent the CDM function in internal and external meetings, providing expert guidance on data-related matters.