Director, Clinical Data Management

About Us:

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 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.

Job 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.

Qualifications:

Education

• BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.

Experience

• 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

Licenses or Certifications

None

Travel Required:

5%

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $210,000-$275,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.