Director, Clinical Data Management

Structure Therapeutics•South San Francisco, CA

16d•$210,000 - $275,000

About The Position

Reporting to Senior Director, the head of clinical data management (CDM), this position will be responsible for coordinating with CDM partner CRO to set up the pivotal AI enabled system to facilitate the automated data review and cleaning. Meanwhile, the individual is responsible for leading the data managers assigned to plan, implement, and manage CDM CRO activities on assigned clinical programs and 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 individual needs to have a detailed knowledge of data management platform and software, clinical trial databases, and pharmaceutical / BioPharma drug development process.

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

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.