Sr. Clinical Data Manager
3350 W. Bayshore Rd. Palo Alto, CA 94303 US
The Senior Clinical Data Manager or Manager of Clinical Data Management will be responsible for leading and coordinating Data Management (DM) deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy, and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.
What You'll Do
- The EDC build (set-up, eCRF design, database validation, etc) and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks.
- Ensure optimized data collection, flow and access across EDC and non-EDC data sources.
- Responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases.
- Develop and implement data structure standards based on CDASH/SDTM.
- The role will operate as a key member of the Clinical Operations team working closely with other departments.
- Serve as primary contact for DM with all relevant parties both internally (e.g., Project Management, Clinical Monitoring, Biostatistics, and other functional groups) and externally (e.g., external vendors, investigational sites)
- This position also provides leadership and expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.
- Provide strategic input into the design of data flow across EDC and non-EDC data sources.
- Creatively define, develop, implement, and enforce use of systems that simplify and improve clinical data capture and quality e.g., continuously test clinical data systems to identify functional issues, define and execute mitigation strategies to identify functional issues and anomalous data, etc., plan and project the resources required including management of tasks, timelines, risk, and quality.
- Keep track of the DM budget, forecasts and manage changes of scope requests.
- Participate in the review of study documents (e.g., protocol, electronic case report forms (eCRFs), safety plans/manuals and statistical analysis plan).
- Develop, review, and maintain project-specific DM documents including data management plans(DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements.
- Provide project metric reports, status updates, study progress, feedback, and advice to project team on site performance issues, data trends and protocol non-compliance etc.
- Perform and/or coordinate various data reconciliation activities; examples include (but not limited to) UADEs, medical conditions, and (other) external laboratory data, etc.
- Contribute as Subject Matter Expert (SME) in the field of CDM activities to the evaluation/improvement and standardization of processes and procedures within the Quality Management System.
What You'll Bring to the Team
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
- Minimum of 8 years of data management experience preferably in the diagnostic industry and/or pharmaceutical/biotechnology industries.
- Experience with web-based EDC software systems (Castor, Rave, ClinCapture, Medidata, etc.) and other tools for managing clinical studies (medical coding dictionaries such as MedDRA and WHO Drug.
- Experience in CDISC conventions, i.e., CDASH, TAUGs, SDTM terminology and hands on experience implementing these models.
- In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
- Experience in development and implementation of Clinical data management standards and procedures and preemptively identify data and system issues, and mitigate risks to data quality.
- Knowledgeable, thorough experience with relational database components with development, validation, execution, maintenance, documentation, testing, and archival of clinical data.
- Highly detail oriented with special attention to quality and quality control.
- Ability multitask and handle multiple responsibilities simultaneously; able to prioritize.
- Well organized and able to work under tight deadlines.
- Excellent interpersonal skills, including verbal and written communication.
- Ability to work in a fast-paced and informal startup environment.
- Strong problem-solving skills with desire to improve upon established processes.
- Ability to simplify complex issues into understandable concepts.
- Ability to translate guidelines, rules, and regulations in clear and usable recommendations.
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