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 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.

Job 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.

Qualifications:

Education

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

Experience

• 8+ years of clinical data management experience in pharmaceutical, biotech and/or CRO’s
• Extensive experience with different modules on Medidata Platform

Licenses or Certifications

None

Travel Required:

 None

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 $165K-$202K. 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.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Structure Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.

Fraud Alert

To all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics, direct candidates to apply through our official career page at BambooHR.

Recruiters will always contact you using the domain of Structuretx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics, please email human resources.