Senior Manager, Clinical Data Management
$165k - $202kStructure Therapeutics Inc.
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. 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. Conduct regular data reviews to make sure all 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 CROs. Extensive experience with different modules on Medidata Platform. Licenses or Certifications None Travel Required None Equal‑Opportunity Employer Structure Therapeutics Inc. is an Equal‑Opportunity Employer. Compensation & Benefits 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. #J-18808-Ljbffr
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