Director, Clinical Data Management
Clinical | Mountain View, CA | Full Time
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
This position oversees the daily Clinical Data Management (CDM) support for a dynamic and fast-growing company. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, database snapshots, study unblinding and database locks. He/she ensures optimized data collection, flow and access across EDC and non-EDC data sources. Responsible for accuracy, consistency, completeness and CDISC compliance of all ChemoCentryx clinical databases
Essential Duties and Responsibilities
- Work in cooperation with Head of Biometrics to select and maintain preferred vendor network for CDM
- Provide strategic input into the design of data flow across EDC and non-EDC data sources across vendor network to ensure accuracy, completeness and compliance (including CDISC)
- Manages data management service providers to ensure the quality of deliverables and that timelines are met
- Oversee or execute on all clinical data management activities and lead strategic initiatives for the function.
- Central point of contact and accountability for internal and CRO study teams for data related deliverables, documentation and risks/mitigation plan
- Accountable for defining the requirements for collection forms for new study protocols to ensure protocol required data for study are collected on eCRF. Approve final EDC for all clinical trials. Work with EDC vendor to resolve any issues.
- Perform UAT of prototype EDC and review eCRF flow dynamics and edit check specifications created by EDC vendor.
- Review and approve data transfer plan for any external data that are imported into EDC (e.g. central lab and biomarker data).
- Coordinate and lead internal and external clinical data review activities for completeness, accuracy and consistency in accordance with the data management plan for all studies on an ongoing basis. Consolidate review comments and ensure resolution of issues identified
- Manages and oversees reconciliation between EDC and non-EDC database, such as, SAE, Lab and biomarker.
- Coordinate activities to lock clinical databases: Develop timelines/milestones for data cleaning, identify data review tasks, and assign and coordinate data review activities to internal and external resources.
- Manage and lead the design and implementation of CDM processes with vendors, including overseeing vendors responsible for creating EDC systems and transferring external data into EDC.
- Approve Data Management Plans, Data Transfer Agreements, Edit Check Specifications, any changes to EDC.
- Provides accurate and timely ad hoc data listing reviews for ChemoCentryx clinical team
- Ensure data quality of clinical database through implementation of CDISC compliance
- Works collaboratively with biometric team, clinical development, clinical operations and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- B.Sc/B.A or higher in science, math or computer science
- 10+ year hands-on CDM experience in clinical trial industry (pharma or biotech preferred)
- Experience managing Data Management CROs
- Knowledge and experience with MedDRA, WHODrug and other Thesaurus classification of controlled management systems
- Hands-on experience of CDISC/SDTM
- Proven experience in locking multiple study databases.
- Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
- Proven ability to preemptively identify data and system issues, and mitigate risks to data quality.
- Work independently and with small teams in a fast-paced, non-traditional work environment in a start-up, clinical stage biotechnology company.
- Hands-on experience working with Relational database (e.g. Rave, Medrio, Inform), and SQL, SAS, and clinical data management systems
- In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
- Demonstrated strong project management and interpersonal communication skills in clinical development
- Manage development and periodic review of CDM specific SOPs