Lead Clinical Data Manager jobs in United States
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Redbock - an NES Fircroft company · 2 days ago

Lead Clinical Data Manager

Redbock, an NES Fircroft company, is seeking a Lead Clinical Data Manager to oversee clinical data management activities for oncology development programs. The role involves managing external CROs and ensuring the accuracy and integrity of clinical trial data throughout the trial process.

BiotechnologyConsultingMedical DevicePharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Shanna Blue
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Responsibilities

Lead and oversee end-to-end clinical data management activities for assigned clinical trials, including study start-up, conduct, and close-out
Provide CRO oversight, ensuring performance, quality, timelines, and contractual deliverables are met
Develop, review, and maintain key data management deliverables, including:
Data Management Plans (DMPs)
ECRF design and completion guidelines
Edit check and data validation specifications
External data transfer and reconciliation plans
Provide oversight of EDC database design, build, validation, and User Acceptance Testing (UAT)
Oversee ongoing data review, discrepancy management, coding activities, and reconciliation of external data sources (e.g., labs, ECG, imaging)
Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and Safety to ensure integrated data delivery and readiness for interim analyses, database lock, and regulatory submissions
Support database lock activities and ensure inspection-ready documentation and processes
Identify data-related risks and proactively implement mitigation strategies to ensure data quality and compliance
Contribute to the development and maintenance of data management SOPs, processes, and best practices

Qualification

Clinical data managementEDC systemsOncology clinical trialsCRO managementData Management PlansRisk managementCollaboration skills

Required

10+ years of clinical data management experience in a pharmaceutical or biotechnology setting and bachelor's degree
Demonstrated experience leading data management activities for clinical trials from study start-up through database lock
Prior experience in oncology clinical trials
Hands-on experience with EDC systems
Experience managing CROs and external vendors in a sponsor environment

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.

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