Clinical Data Manager

Who We Are
Vial is a next-generation, tech-first CRO delivering faster, more efficient clinical trials at dramatically lower costs for biotech sponsors. Our mission is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives.
We are more than just a CRO — we are "doers". We are reimagining clinical trials and have assembled a talented team of executives from Silicon Valley and industry-leading CROs. Together, we have built a global, full-service CRO powered by intuitive end-to-end technology.
Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO).
Vial is a San Francisco, California-based company founded by Simon Burns and Andrew Brackin in October 2020. Since our founding, we have become a fast-growing company of 100+ employees with over $100 million in funding.
Vial is building towards a more efficient future for clinical trials. By deploying technology in every step of a trial, we are driving efficiencies in speed and cost that we pass on to innovative biotech startups. Ready to join us on our journey to reimagine clinical trials?
What You'll Do
OverviewWe’re looking to hire a Clinical Data Manager. Our Clinical Data Manager will will contribute to data management activities in support of studies across all stages of clinical drug development.
This role is fully remote, based anywhere in the US. Unfortunately, we are not able to provide sponsorship to work in the United States.

Key Responsibilities

• Contribute to and oversee data management activities in support of clinical studies, including:
• Database build activities, including review of edit check specifications and preparing study-specific go-live documentation
• Oversee and establish Data Management Plans and internal data management procedures
• Oversight of eCRF development process, including leading cross-functional reviews and ensuring adherence to CDISC standards
• Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
• Oversight of database lock activities, including oversight of SDTM and ADaM dataset conversions, data transfers, and study data archival
• 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
• 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.
• Support GCP inspection readiness

Who You Are:

• BS/BA in scientific discipline with over 4 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
• Experience working with multiple EDC systems, such as Medidata Rave EDC, Veeva Vault, etc
• Experience using standardized medical terminology, including MedDRA and WHODrug
• Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project
• Highly motivated and flexible, with excellent organizational and time management skills
• Understanding of ICH GCP, GCDMP, 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

Nice to Have

• Active, relevant certifications pertaining to Good Clinical Data Management Practices, such as Certified Clinical Data Manager (CCDM)

Annual Salary Range: $75,000 - 100,000 USDFinal offer amount will depend on education, skills, experience, and location.
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Why You’ll Love Working At Vial
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