Director, Clinical Data Management
Structure Therapeutics
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.
POSITION SUMMARY
The Director, Clinical Data Management (CDM), reporting to Senior Director, head of CDM, will oversee and management the strategic and operational aspects of data management in support of clinical development activities for assigned programs and studies. 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. This position may have direct supervisory responsibilities for external consultants. This is a hybrid role that will require 3 days in the office (2 core days and 1 flex day). #LIHybrid
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead, mentor, and develop the study data managers, fostering their growth and ensuring their success in managing clinical trial data. Conduct performance evaluation and support career development for the direct reports
- 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
- Stay informed about emerging technologies and trends in clinical data management, such as Electronic Data Capture (EDC), Artificial Intelligence (AI), Machine Learning (ML), and evaluate their potential integration into clinical trials
- Supervise the development, validation, and production release of all clinical databases in accordance with both Structure and CRO SOPs and working instructions, and also 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.
- 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
- Strong leadership and team management skills, with the ability to mentor develop talent
- 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, 10+ 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 - Up to 10-20%
The target salary range for this full-time role is $214,000 - $257,000 + 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.