About IDEAYA Biosciences:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see www.ideayabio.com.
IDEAYA is seeking a talented and highly motivated Senior Clinical Data Manager / Associate Director of Data Management (DM). This individual will be responsible for leading clinical data activities across multiple studies from study start-up to study closure for IDEAYAs early stage clinical programs.
As a Senior Clinical Data Manager or Associate Director, you will play a key role in providing oversight to ensure complete, accurate and high-quality data collection for outsourced trials. In addition, you will provide leadership within the organization to develop and implement 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.
What youll do:
- Provide leadership for clinical data management (CDM) function; ensure DM deliverables are completed on time, within budget and in accordance with quality standards and study requirements
- Responsible for leading CDM activities for multiple trials; responsible for the oversight of CRO and/or CDM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements
- Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial
- Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization outputs
- Write or contribute to preparation of CDM documents (e.g., Case Report Form [CRF] 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, migration 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., IxRS, laboratory, Imaging)
- Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors
- In collaboration with Study Execution Team (SET), participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock Tables, Figures and Listings (TFLs)
- Report DM metrics and trends; identify barriers to timely and successful trial execution and propose solutions
- Lead clinical data review of data listings and summary tables with the SET
- Implement data review strategy via use of data integration or visualization platform
- Serve as a subject matter expert on CDM systems and processes
- Lead CDM standardization and development of Standard Operation Procedures (SOPs), work instructions and other infrastructure as needed; may include standard CDASH case report form library and associated edit checks
AKA, what you will bring:
- Bachelors in life sciences or related discipline with 6-8 years of experience in clinical data management
- CRO or CDM vendor management experience in oncology
- Early phase adaptive trial management experience preferred
- Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding
- Experience with SAS programming techniques is a plus
- For Associate Director, line management experience is a plus
- 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
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 team work to move science forward.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets