Senior Clinical Data Manager - Katalyst Healthcares & Life Sciences
West Menlo Park, CA 94025
About the Job
Responsibilities: Develop requirements for EDC including CRF and system design; performs and organizes all aspects of the clinical database build and cross-functional User Acceptance Testing (UAT).
Develop report specifications for routine data reviews; assist with programming and QC of output.
Perform routine data quality activities including review of standard study reports, query identification and resolution, and recommendations for improved data cleaning and collection.
Collaborate with cross functional study team for data reviews and data cleaning activities.
Maintain user accounts in compliance with regulatory requirements and SOPs.
Review/revise DM related study plans including Data Quality Management Plan, Data Validation Plan, Data review plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
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.
Knowledge of industry standards (CDISC, SDTM, CDASH).
In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
Proven ability to pre-emptively identify data and system issues, and mitigate risks to data quality.
Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
Experience in development and implementation of Clinical data management standards and procedures.
Experience with web-based EDC (IBM Clinical preferred), clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
A background in programming is preferred.
Requirements: BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
Strong expertise in project/program management including stakeholder management.
6 years of data management experience in the pharmaceutical or biotechnology industries.
Highly detail oriented with special attention to quality and quality control.
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize.
Excellent problem resolution and organizational skills; desire to improve upon established processes.
Strong interpersonal skills, including verbal and written communication, are essential.
Ability to work independently and as part of a team
Develop report specifications for routine data reviews; assist with programming and QC of output.
Perform routine data quality activities including review of standard study reports, query identification and resolution, and recommendations for improved data cleaning and collection.
Collaborate with cross functional study team for data reviews and data cleaning activities.
Maintain user accounts in compliance with regulatory requirements and SOPs.
Review/revise DM related study plans including Data Quality Management Plan, Data Validation Plan, Data review plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
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.
Knowledge of industry standards (CDISC, SDTM, CDASH).
In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
Proven ability to pre-emptively identify data and system issues, and mitigate risks to data quality.
Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
Experience in development and implementation of Clinical data management standards and procedures.
Experience with web-based EDC (IBM Clinical preferred), clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
A background in programming is preferred.
Requirements: BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
Strong expertise in project/program management including stakeholder management.
6 years of data management experience in the pharmaceutical or biotechnology industries.
Highly detail oriented with special attention to quality and quality control.
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize.
Excellent problem resolution and organizational skills; desire to improve upon established processes.
Strong interpersonal skills, including verbal and written communication, are essential.
Ability to work independently and as part of a team
Source : Katalyst Healthcares & Life Sciences