Senior Clinical Data Manager

Job Summary

About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Position Summary

IDEAYA is seeking a talented and highly motivated Senior Clinical Data Manager, Data Management (DM). This individual will be responsible for leading all aspects of the data management process from study start-up to study closure for IDEAYA’s late phase clinical program. As a Senior Clinical Data Manager, you will play a key role in ensuring complete, accurate and high-quality data collection for clinical trials. In addition, you will provide leadership within the organization to develop and improve clinical data management standards and processes.

What you’ll do

• Provide leadership for clinical data management function; ensure data management deliverables are completed on time, within budget and in accordance with quality standards and study requirements
• Responsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the oversight of CRO and/or DM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements
• Represent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updates
• Establish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trial
• Collaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverables
• Develop and maintain study-specific DM documents (e.g., electronic Case Report Form (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)
• Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelines
• Maintain study DM related documents for inspection readiness
• Develop data transfer agreements with external vendors
• Review and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)
• Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutions
• Lead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategy
• Serve as a subject matter expert on data management systems and processes
• Contributes to the development and improvement of data management standard operating procedures (SOPs) and document templates

Requirements

• Bachelor's in life sciences or related discipline with at least 8 years of experience in clinical data management
• Extensive knowledge of clinical data management principles, clinical trials process and regulatory requirements
• Strong experience with late phase oncology trials is preferred
• Strong verbal and written communication and critical thinking skills
• Experience in Veeva CDMS system is a plus
• Experience with MedDRA and WhoDrug medical coding
• Excellent ability to manage competing priorities in a changing environment
• Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines
• Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization
• Self-motivated and takes pride in your work
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
• Adequate attention to detail, ability to proactively identify issues and address with solutions-oriented approach

Total Rewards

• Competitive total rewards package that reflects our pay-for-performance philosophy
• Merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval)
• Comprehensive benefits package including, but not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs