Our client is a biotech company focused on developing breakthrough therapies in Oncology. The Senior Manager, Clinical Data Management will be responsible for timely and high quality data management deliverables supporting our client's portfolio. The ideal candidate will have a strong background in oncology and substantial experience in Data Management within the biotech or pharmaceutical industry. This job will be hybrid on site in the client's San Francisco Bay Area office.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Provides input into the design of data flow across EDC and non-EDC data sources across internal stakeholder and vendor network
- Contributes influential leadership in collaboration with other Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Partners with appropriate stakeholders and vendors to mitigate and resolve risks as well as to ensure the quality of deliverables and that timelines are met
- Develops and contributes to the design of processes enabling near-real-time data access for client's clinical trials
- Reviews and critically assesses data query resolution metrics and suggests process improvement
- Reviews study protocols to ensure that data collection and CRF design meet study objectives
- Manages and oversees SAE and external vendor reconciliation between clinical and applicable databases
- Review clinical data for completeness, accuracy, and consistency in accordance with the investigational plan
- Champions and adopts technology improvements and tools for use in clinical data management processes.
- Support the development and periodic review of Data Management specific SOPs, WIs, and templates
- Provide subject matter expertise prior, during, and post internal and external audits and inspections
- Maintain compliance with company and study-specific learning requirements
- Performs other duties as assigned
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- BS/BA or higher required preferably in science, math, or computer science
- Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
- Experience with Oncology clinical trials
- Ability to handle multiple development programs simultaneously.
- Experience with management of data flow and curation of biomarker data
- Experience managing Data Management CROs and vendors
- Relational database experience, SAS, and clinical data management systems
- Knowledge of CDISC/SDTM. Hands-on experience preferred
- Hands-on experience working with mainstream EDC systems
- Familiarity with Data Visualization Tools for quick customized data access
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Demonstrated strong management abilities for project and staff management of Data Management Deliverables in clinical development