Lead Clinical Data Manager jobs in United States
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Redbock - an NES Fircroft company ยท 1 day ago

Lead Clinical Data Manager

positionUnited States
timeContract
remoteRemote
seniorityLead/Staff
money$75/hr - $95/hr
date10+ years exp

Redbock, an NES Fircroft company, is a clinical-stage biotechnology company based in San Francisco seeking an experienced Lead Clinical Data Manager to provide hands-on leadership and oversight for clinical trials. The role involves leading Data Management activities, collaborating with cross-functional teams, and ensuring high-quality clinical data for regulatory submissions.

BiotechnologyConsultingMedical DevicePharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Kalyn Burer
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Responsibilities

Serve as the Data Management Lead for assigned clinical studies from study start-up through database lock (typically 1-2 studies concurrently)
Develop, maintain, and execute core Data Management deliverables, including Data Management Plans, CRFs/eCRFs, data validation specifications, and data transfer documentation
Provide hands-on SAS programming support, including development of basic clinical data listings, data checks, and ad hoc analyses; serve as backup support for the study SAS Programmer
Oversee database design, edit check development, and UAT activities
Lead CROs and external data vendors to ensure data quality, regulatory compliance, and on-time deliverables
Conduct proactive data review and discrepancy management across EDC, eCOA, safety, and laboratory systems
Support regulatory submissions (NDA, sNDA, BLA), including data quality review, anonymization activities, and inspection readiness
Ensure compliance with GCP, ICH, and applicable regulatory and industry standards
Communicate study risks, timelines, and deliverables effectively to internal stakeholders

Qualification

SAS programmingClinical data managementEDCECOA systemsRegulatory submissionsData quality principlesLeadershipCommunicationCollaboration

Required

10+ years of extensive clinical data management experience within pharma or biotech environments
Demonstrated experience serving as Lead Clinical Data Manager on clinical trials
Minimum of 1+ year of hands-on SAS programming experience in a clinical data environment, with ability to write and modify SAS code to support clinical data review and reporting
Strong understanding of clinical trial data flow, data quality principles, and end-to-end data lifecycle management
Advanced experience with EDC and eCOA systems (e.g., Medidata Rave, Veeva)
Proven experience overseeing CROs and external vendors

Preferred

Experience supporting regulatory submissions strongly preferred

Company

Redbock - an NES Fircroft company

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Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
dateFounded in 2010
location
Cupertino, California, USA
people-size51-200 employees
web-link
http://redbock.com/

H1B Sponsorship

Redbock - an NES Fircroft company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2018-06-20Acquired
Company data provided by crunchbase