Sr. Clinical Data Manager jobs in United States
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Katalyst CRO ยท 2 months ago

Sr. Clinical Data Manager

positionSan Diego, CA
timeContract
remoteOnsite
senioritySenior Level
date5+ years exp

Katalyst CRO is a clinical research organization, and they are seeking a Senior Clinical Data Manager to oversee data management activities across trials. The role involves managing database design, identifying risks, and ensuring data integrity while supporting cross-functional activities related to biometrics and regulatory submissions.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Oversee data management activities to maintain consistency across trials including Case Report Form (CRF) design, Data Management Plans, CRF annotation, edit check programs, data entry and query status tracking, and database closure
Oversee database design, migration or expansion, including UAT and documentation
Proactively identify risks and execute risk mitigation strategies; Maintain timely communication with both upper management and cross-functional teams
Oversee the tracking of important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team as required
Perform reviews of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
Support cross-functional activities related to biometrics, regulatory submissions and clinical program development as needed

Qualification

CDM experienceClinical research principlesCDMS proficiencyMicrosoft Office SuiteRisk managementProject managementCommunication skills

Required

Minimum of 5+ years of CDM experience in biotech or pharmaceutical industry; or equivalent education and experience required
Ability to manage multiple programs, and multiple studies within a program
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Experience supporting Phase 3 studies, BLA submission and FDA/MHRA audits
Proficient in CDMS (ex: Medidata, Clintrak), Microsoft Office Suite (ex: Word, Excel, PowerPoint)
Understand the principles of clinical research (ex: ICH GCP, CDISC and GCDMP)

Preferred

BS degree in a life science or related field preferred

Company

Katalyst CRO

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Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
http://katalysthls.com

H1B Sponsorship

Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)

Funding

Current Stage
Growth Stage

Leadership Team

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John Patil
Recruiter, Pharma/CRO Staffing Division
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Recent News

LinkedIn
Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
Company data provided by crunchbase