Associate Director, Clinical Data Management

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 has completed an initial public offering (IPO) in February of 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.#LIhybrid.

Position Summary

The Associate Director, Clinical Data Management (CDM) will report to Senior Director, CDM and support the Head of CDM in leading cross-functional efforts to build out processes and infrastructure necessary to internalize key CDM oversight capabilities and optimize overall operational delivery. The AD is responsible for planning, implementing, and managing CDM CRO activities on assigned clinical 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. This will be an individual contributor role. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).

Essential Duties and responsibilities

• Facilitate and implement the management of CDM deliverables in coordination with both internal and external cross-functional teams.
• Assist the head of data management in establishing standards for electronic Case Report Forms (eCRFs), edit checks, data listings and reports, and data metrics.
• Supervise and ensure all databases are developed, validated and ready for production release according to both Structure and CRO SOPs and working instruction.
• Facilitate database design by the CRO according to the protocol and also in line with Structure global standard library; lead and perform sponsor acceptance testing of the clinical database.
• 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.
• 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.
• 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.

Core Competencies, Knowledge, and Skill Requirements

• Detail-oriented, thorough and well-organized
• In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11and ICH guidelines
• Strong communication (written and oral), decision-making, influencing, and negotiation skills at all organizational levels.
• Ability to work independently and effectively in a fast-paced and collaborative environment.
• Proficient in Medidata Rave and/or other EDC platform study builds and operation
• Experience working with and managing CROs/external vendors, 5+ years preferred
• Experience with regulatory inspection/audit preparation preferred

REQUIREMENTS

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.

 Licenses or Certifications

• None

  Travel

• 5% – 10%

The target salary range for this full-time role is $174,000 - $209,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on 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 with you during the hiring process by the StructureTx Talent Acquisition Team.