Clinical Data Analyst
San Francisco, CA
Applications have closed
Vial
Vial is a global, full-service CRO delivering faster, more efficient clinical trials for biotech, powered by experienced ClinOps and technology leaders.
Who We Are
Vial's vision is to empower scientists to cure all human disease. Vial was founded on a mission to reimagine clinical trials and deliver faster and more efficient trials for sponsors. Through our end to end technology platform, we are delivering on a generational opportunity to make trials radically more efficient.
Vial’s co-founders (Simon Burns and Andrew Brackin) were early team members at $1B+ startups Robinhood, Opendoor and Newfront. Our early team is made up of experienced technology and operations leaders from Apple, Google, Microsoft, Faire, Chime and other leading technology companies.
Vial was founded in Oct 2020 and has grown the team to over 100 across the business. Come join us on our adventure to reimagine clinical trials.
What You'll Do
We’re looking to hire a Clinical Data Analyst to contribute to data management activities in support of studies across all stages of clinical drug development. You'll report to the Director of Engineering.
This role is fully remote.
Key Responsibilities- Utilize the in-house Vial EDC and TrialOS system in day-to-day clinical data management activities- Contribute to data management activities in support of clinical studies, including: eCRF development by leading cross-functional reviews of eCRF content- Database build activities, including review of edit check specifications and performance of user acceptance testing- Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews- Oversight of database lock activities and ultimate archiving of study data.- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality - Assurance, Drug Safety and Pharmacovigilance; CROs, central and local laboratories, and other vendors- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews- Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
Who You Are- BS/BA in scientific discipline with 1-3 years related experience in a pharmaceutical/CRO setting- Strong knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems- Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11- Understanding of ICH GCP as well as general knowledge of industry practices and standards- Experience using standardized medical terminology, including MedDRA and WHODrug- Highly motivated and flexible, with excellent organizational and time management skillsWhy You’ll Love Working At Vial
We are innately curious. We found our calling in clinical trials after learning the pain points directly. It is our curiosity that propels us to keep building, finding new challenges, and fulfilling our vision of reimagining clinical trials.We believe in autonomy. Team members do their best work when given autonomy. In order to make an impact on the scale of the Vial vision, we built our culture to enable each Vial team member to feel ownership of their domain. We take pride in building mastery. We believe in building master in a craft. Craftsmanship, a pride in one’s craft, is key to prolonged engagement on a difficult challenge. Vial’s culture is one of highly autonomous, deeply focused experts working on an immensely hard problem together.Our strength is moving fast and staying humble. We believe that if we build a team that is intellectually honest, that we stay nimble and keep an open mind to all solutions - we’ll be adaptive and solve the problems that face us at every turn.
BenefitsCompetitive Equity CompensationHealth, Dental, and VisionRemote-First Paid Parental LeaveUnlimited Vacation
Vial's vision is to empower scientists to cure all human disease. Vial was founded on a mission to reimagine clinical trials and deliver faster and more efficient trials for sponsors. Through our end to end technology platform, we are delivering on a generational opportunity to make trials radically more efficient.
Vial’s co-founders (Simon Burns and Andrew Brackin) were early team members at $1B+ startups Robinhood, Opendoor and Newfront. Our early team is made up of experienced technology and operations leaders from Apple, Google, Microsoft, Faire, Chime and other leading technology companies.
Vial was founded in Oct 2020 and has grown the team to over 100 across the business. Come join us on our adventure to reimagine clinical trials.
What You'll Do
We’re looking to hire a Clinical Data Analyst to contribute to data management activities in support of studies across all stages of clinical drug development. You'll report to the Director of Engineering.
This role is fully remote.
Key Responsibilities- Utilize the in-house Vial EDC and TrialOS system in day-to-day clinical data management activities- Contribute to data management activities in support of clinical studies, including: eCRF development by leading cross-functional reviews of eCRF content- Database build activities, including review of edit check specifications and performance of user acceptance testing- Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews- Oversight of database lock activities and ultimate archiving of study data.- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality - Assurance, Drug Safety and Pharmacovigilance; CROs, central and local laboratories, and other vendors- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews- Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
Who You Are- BS/BA in scientific discipline with 1-3 years related experience in a pharmaceutical/CRO setting- Strong knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems- Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11- Understanding of ICH GCP as well as general knowledge of industry practices and standards- Experience using standardized medical terminology, including MedDRA and WHODrug- Highly motivated and flexible, with excellent organizational and time management skillsWhy You’ll Love Working At Vial
We are innately curious. We found our calling in clinical trials after learning the pain points directly. It is our curiosity that propels us to keep building, finding new challenges, and fulfilling our vision of reimagining clinical trials.We believe in autonomy. Team members do their best work when given autonomy. In order to make an impact on the scale of the Vial vision, we built our culture to enable each Vial team member to feel ownership of their domain. We take pride in building mastery. We believe in building master in a craft. Craftsmanship, a pride in one’s craft, is key to prolonged engagement on a difficult challenge. Vial’s culture is one of highly autonomous, deeply focused experts working on an immensely hard problem together.Our strength is moving fast and staying humble. We believe that if we build a team that is intellectually honest, that we stay nimble and keep an open mind to all solutions - we’ll be adaptive and solve the problems that face us at every turn.
BenefitsCompetitive Equity CompensationHealth, Dental, and VisionRemote-First Paid Parental LeaveUnlimited Vacation
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Biostatistics Data management Engineering GCP Pharma Statistics Testing
Perks/benefits: Flex hours Flex vacation Health care Team events
Regions:
Remote/Anywhere
North America
Country:
United States
Job stats:
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Category:
Analyst Jobs
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