Senior Clinical Data Manager, Data Management

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. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Amgen, Pfizer, and Gilead but wholly-owns or controls its three most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.   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. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use teamwork to move science forward. For more information, please see www.ideayabio.com.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources.  Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio.  Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com 

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. You should enjoy working with a dynamic and multi-disciplinary team and be able to work independently and collaboratively with key functions both internally and externally.

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

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:

• 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