Job Description

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA.

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.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

• 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

• Bachelors in life sciences or related discipline with 6-8 years of experience in clinical data management
• Requires 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
• Attention to detail, ability to proactively identify issues and address with solutions-oriented approach

The expected salary range for this role that is based in our South San Francisco, California office is $152,864 - $191,475.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).

Total Rewards:

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.

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