Katalyst CRO
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Clinical Data Manager
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Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Clinical Data Manager
role at
Katalyst CRO Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators. Oversight of database lock activities and ultimate archiving of study data. Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors. Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members. Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution. Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.
Responsibilities
Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators. Oversight of database lock activities and ultimate archiving of study data. Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors. Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members. Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution. Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.
Requirements:
BS/BA in scientific discipline. At least 8 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company. Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred. Expert knowledge of clinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems. Experience leading initiatives/projects for SOP, process and standards development within clinical data management. Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation. Experience working with Medidata Rave. Experience using standardized medical terminology, including MedDRA and WHO Drug. Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project. Excellent written and oral communications skills. Highly motivated and flexible, with excellent organizational, time and project management skills. Ability to work independently and as part of a multi-disciplinary team. Understanding of ICH GCP as well as general knowledge of industry practices and standards. Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
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Clinical Data Manager
role at
Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Clinical Data Manager
role at
Katalyst CRO Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators. Oversight of database lock activities and ultimate archiving of study data. Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors. Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members. Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution. Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.
Responsibilities
Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators. Oversight of database lock activities and ultimate archiving of study data. Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors. Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members. Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution. Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.
Requirements:
BS/BA in scientific discipline. At least 8 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company. Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred. Expert knowledge of clinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems. Experience leading initiatives/projects for SOP, process and standards development within clinical data management. Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation. Experience working with Medidata Rave. Experience using standardized medical terminology, including MedDRA and WHO Drug. Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project. Excellent written and oral communications skills. Highly motivated and flexible, with excellent organizational, time and project management skills. Ability to work independently and as part of a multi-disciplinary team. Understanding of ICH GCP as well as general knowledge of industry practices and standards. Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Clinical Data Manager jobs in
San Francisco, CA . Alameda, CA $86,700.00-$173,300.00 9 hours ago San Francisco, CA $145,000.00-$180,000.00 2 weeks ago Associate Clinical Data Management Director
Alameda, CA $160,000.00-$226,500.00 1 week ago Senior Manager, Clinical Data Management
Senior Manager, Clinical Data Management
Senior Manager, Clinical Data Management
San Francisco, CA $190,000.00-$200,000.00 3 days ago Alameda, CA $86,700.00-$173,300.00 2 days ago Principal Data Manager - Clinical Data Quality Leader
Senior Manager, Clinical Data Management
Associate Director, Clinical Programming
Alameda, CA $179,500.00-$255,500.00 1 week ago Alameda County, CA $190,000.00-$225,000.00 3 weeks ago Senior Director, Clinical Data Management
Redwood City, CA $265,000.00-$295,000.00 3 days ago Associate Director, Clinical Programming
Alameda, CA $179,500.00-$255,500.00 2 weeks ago Associate Director, Clinical Data Management
Senior Director, Clinical Data Management
Associate Clinical Data Management Director
Alameda, CA $160,000.00-$226,500.00 1 week ago Vice President, Clinical Data Management
Alameda, CA $331,000.00-$384,500.00 2 weeks ago Alameda, CA $86,700.00-$173,300.00 1 week ago Sr. Manager, Global Study Operations (GSO)
Sr. Manager, Global Study Operations (GSO)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr