Senior Manager, Clinical Data Management
Structure Therapeutics is seeking a Senior Manager, Clinical Data Management to oversee and manage data management activities for assigned clinical studies. This role involves planning, implementing, and managing Clinical Data Management (CDM) activities, including database and technology selections, vendor management, and data collection, ensuring quality standards and timelines are met. The Senior Manager will collaborate closely with cross-functional teams, including Clinical Operations, Biostatistics, Clinical Development, and Regulatory Affairs, to align data management activities with the overall clinical development strategy and regulatory requirements. This is a hybrid role requiring three days in the office (two core days and one flex day).
Key responsibilities include acting as the primary point of contact for data management activities for assigned clinical studies, providing expertise to internal and CRO cross-functional teams. The role involves establishing standards for electronic Case Report Forms (eCRFs), edit checks, data listings and reports, and data metrics. The Senior Manager will supervise the development, validation, and production release of all clinical databases according to both Structure Therapeutics and CRO Standard Operating Procedures (SOPs) and working instructions. Additionally, the role includes facilitating database design by the CRO in line with Structure's global standard library, leading and performing sponsor acceptance testing of the clinical database, and contributing to the development and review of all data management documentation.
The ideal candidate will have a Bachelor’s or Master’s degree in Life Sciences, Informatics, Computer Sciences, or related fields, with at least 8 years of clinical data management experience in pharmaceutical companies and/or CROs. Experience with complex and international trials is desired. The candidate should be detail-oriented, thorough, and well-organized, with in-depth knowledge of FDA regulations, Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), Clinical Data Interchange Standards Consortium (CDISC) standards, 21 CFR Part 11, and International Council for Harmonisation (ICH) guidelines. Strong communication, decision-making, influencing, and negotiation skills at all organizational levels are essential. Proficiency in Medidata Rave and/or other Electronic Data Capture (EDC) platforms is required, along with experience working with and managing CROs/external vendors. Experience with regulatory inspection/audit preparation is preferred.
The target salary range for this full-time role is $168,000 to $202,000, plus bonus, equity, and benefits. Structure Therapeutics determines salary ranges based on the level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education, and training. More details about the specific salary range for your location will be discussed during the hiring process by the Structure Therapeutics Talent Acquisition Team.
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. With offices in California and Shanghai, Structure Therapeutics is at the center of life science innovation in both the US and China, capitalizing on the strengths of each geographic location.