Sr. Director, Clinical Data Management - South San Francisco, United States - Structure Therapeutics

Description

Job Description

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 recently completing a second financing round to support clinical development of our lead assets. 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 Sr. Director, Clinical Data Management (CDM) will be responsible for the operational and strategic aspects of data management across the organization, including data governance, data quality, and data strategy. The position will work with CRO partners to promote consistency in data collection, reporting and structure. It oversees the daily CDM support for a dynamic and fast-growing company. This includes the EDC build and UAT, study data cleaning and reconciliation, query issue and resolution, database snapshots, study unblinding and database locks. He/she ensures optimized data collection, flow and access across EDC and non-EDC data sources. The position is responsible for accuracy, consistency, completeness and CDISC compliance of all Structure's clinical databases. He/she is expected to provide strategic input in evaluating and recommending new technologies for implementation to maintain industry standards, ensuring compliance with applicable regulatory requirements, and assessing new SOPs prior to approval and implementation.#hybrid.

Reporting to the VP, Biometrics, this leader will become a driving force of delivery and excellence providing leadership, oversight, and technical/strategic direction to the CDM function.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversee CRO data management and/or contract data management staff and contributes to the development of clinical data management within the company
• Collaborate with clinical development team to develop short-term and long-term strategies to improve data management quality and efficiency. This includes personals, CDM service models and EDC systems to support the expanding clinical programs
• Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards
• Review and provide feedback on study documents such as study management plans, specifically data management plans, study protocols, Statistical Analysis Plans, CSRs and other documents as required
• Coordinate and lead internal and external clinical data review activities for completeness, accuracy, and consistency in accordance with the data management plan for all studies on an ongoing basis. Consolidate review comments and ensure resolution of issues identified
• Develop/Implement CRF standard for data collection to complete project deliverables on schedule and according to quality standards and requirements of the study
• Lead the development and maintenance of Standard Operating Procedures (SOPs) and Work instructions related to data management activities
• Co-lead vendor and technology evaluation, qualification, and selection
• Work closely with IT and QA to ensure that system infrastructure meet Biometrics needs and industry regulations and best practices.
• Define requirements for collection forms for new study protocols to ensure protocol required data for study are collected on eCRF. Approve final EDC for all clinical trials. Work with EDC vendor to resolve any issues.
• Perform user acceptance testing of prototype EDC and review eCRF flow dynamics and edit check specifications created by EDC vendor.
• Review and approve data transfer plan for any external data that is imported into EDC (e.g., central lab and biomarker data).
• Manages and oversees reconciliation between EDC and non-EDC database, such as, SAE, Lab, and biomarker.
• Coordinate activities to lock clinical databases: Develop timelines/milestones for data cleaning, identify data review tasks, and assign and coordinate data review activities to internal and external resources.
• Manage and lead the design and implementation of CDM processes with vendors, including overseeing vendors responsible for creating EDC systems and transferring external data into EDC.
• Review/ Approve Data Management Plans, Data Transfer Agreements, Edit Check Specifications, any changes to EDC In collaboration with clinical operations, biostat, clinical science
• Educate clinical team members as needed regarding data management processes, workflow, and data standards that may have direct impact on their work
• Responsible for managing and tracking work orders associated with clinical data management activities to ensure that the operating costs for the data management department are achieved within budget
• Cultivate effective, collaborative, and productive working relationships with colleagues, subordinates, vendors, and management as well as solve problems and escalate issues with proposed solutions to senior management as needed
• Other duties as assigned.

Core Competencies, Knowledge and Skill Requirements

• In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11 and ICH guidelines
• In-depth knowledge of clinical trial process, EDC systems (i.e., Medidata Rave, InForm, etc.), SQL, database programming, clinical operations, quality management, and systems applications to support operations
• Knowledge and experience with MedDRA, WHODrug and other Thesaurus classification of controlled management systems
• Proven experience in locking multiple study databases.
• Successful management of and good working relationship with outside vendors, including CDM CROs
• Ability to negotiate and influence and drive results across a matrix & cross-functional organization.
• Good judgment in evaluating benefits and risks and providing sound recommendations.
• Demonstrated leadership in providing strategic direction to team/project and effectively manage through unexpected events and competing priorities with internal and external partners.
• Management of a budget, inclusive of resourcing and outsourcing and discretionary spend.
• Proficiency in the data management processes
• Excellent written and oral communication skills with the ability to communicate clearly to all organizational levels
• Must be able to work independently in a fast-paced and collaborative environment
• Work well in a collaborative team environment, and have good organizational, communication and interpersonal skills
• Excellent knowledge and skills with the broad technology landscape with strong experience in demonstrating appropriate balance of business and technical capabilities.
• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

REQUIREMENTS

Education

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

Experience

• 12+ years of clinical data management experience in pharmaceutical and/or CRO's
• Complex and international trails experience desired
• Travel
  • 5% – 10%

The target salary range for this full-time role is $255, ,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.