Clinical Data Manager jobs in California

Clinical Data Manager manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Being a Clinical Data Manager standardizes data management procedures and documents departmental operating procedures. May require an advanced degree. Additionally, Clinical Data Manager typically reports to a manager or head of a unit/department. The Clinical Data Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Data Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Manager, Clinical Data Management
  • JenaValve Technology, Inc.
  • Irvine, CA FULL_TIME
  • Job Details

    Job Location

    Irvine, CA

    Position Type

    Full Time

    Education Level

    4 Year Degree

    Salary Range

    $145,000.00 - $150,000.00 Salary/year

    Description

    Job Title : Manager, Clinical Data Management

    Supervisor/Manager Title: Director, Clinical Affairs

    Job Description Summary: The Clinical Data Management Manager contributes to the overall conduct and timely execution of JenaValve clinical trials by overseeing clinical database (design & validate, maintain and shutdown EDC) for clinical trials and overseeing data quality related appropriate clinical databases, and participating in the review and analysis of clinical data. The candidate closely collaborates with other JenaValve cross-functional teams (Study Management, Field Monitoring, Regulatory Affairs, Safety, etc.) in achieving corporate objectives. The role will ensure the quality and integrity of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues.

    Job Responsibilities:

    • Oversee, manage, and execute the development of clinical database design and implementation for JenaValve clinical studies, including User Acceptance Testing (UAT), query logic and language, edit checks, roles, and permissions and CRF completion guidelines and requirements as needed for specific databases.
    • Collaborate with Clinical and Medical Affairs personnel and other appropriate stakeholders such as Study Management team to develop Data Management Plans and Data Surveillance Plans (as applicable) for clinical studies.
    • Develop EDC training materials and documentation.
    • Be responsible for data analysis with Study Management and statistical experts and consultants.
    • Manage timelines and milestones associated with database design, data review, and database locks/freezes with internal resources and/or external vendors.
    • Oversee the overall quality of data and proactively identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns to key deliverables.
    • Work closely with the Study Management team, including study managers, clinical field monitors to ensure quality of clinical data through appropriate data collection and review.
    • Develop and manage data management quality documentation including Department Standard Operating Procedures (DSOPs) and Work Instructions (WIs) as needed.
    • Prepare and support vendor and agency audits as assigned.
    • Hire and manage clinical data team members as needed.

    Qualifications

    Required Education and Experience:

    • 8 years of increasing experience in clinical data management phases is required (preferred in medical devices).
    • Technical skills in clinical databases and reporting tools (e.g. Castor, Medidata Rave, Oracle EDC) is preferred.
    • B.S. or B.A. in biological or medical/clinical sciences preferred with 5 years functioning as a lead data manager. Advanced degree is preferred.
    • Working knowledge of GCPs, Clinical Quality and Compliance and Regulatory requirements related to clinical research.
    • Working knowledge of data management practices.
    • Strong organization skills and time management in a dynamic environment; ability to work on multiple projects.
    • Good critical thinking and sound communication skills.
    • Self-motivated and detailed oriented.

    Skills and Abilities Required for This Job:

    • Knowledge of GCP governing the conduct of clinical trials; working knowledge of Medical Device regulations and ICH Guidelines.
    • Demonstrated experience working with all phases of study conduct: start-up, maintenance, and closeout.
    • Experience with driving activities for interim and final database locks for regulatory submissions, publications, and podium presentations, and clinical trial data audits.
    • Experience writing SOPs and work instructions.
    • Must have ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.
    • Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
    • Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.
  • 2 Days Ago

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Sr. Clinical Data Manager
  • Glaukos Corporation
  • San Clemente, CA FULL_TIME
  • How will you make an impact? The Sr. Clinical Data Management Specialist, based in Aliso Viejo, works in coordination with Data Management, Biostatistics, Programming and Clinical Operations teams. Ex...
  • 2 Days Ago

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Clinical data manager
  • Integrated Resources INC
  • Foster, CA FULL_TIME
  • Job DescriptionSpecific Responsibilities:The selected candidate will manage biomarker data in various stages, from planning, to set-up, conduct, closeout, and archiving, in high volume, while maintain...
  • 4 Days Ago

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Clinical Data Manager
  • Zymeworks Inc.
  • San Francisco, CA FULL_TIME
  • Company DescriptionZymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific an...
  • 6 Days Ago

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Sr. Clinical Data Manager
  • Precision Medicine Group
  • Costa Mesa, CA FULL_TIME
  • This position is 100% remote*Position SummaryThe Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database ...
  • 8 Days Ago

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Sr. Clinical Data Manager
  • Precision For Medicine
  • Costa Mesa, CA FULL_TIME
  • This is a 100% remote position**Position SummaryThe Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post databa...
  • 8 Days Ago

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Clinical Data Manager
  • Meet
  • About the Opportunity: We are partnering up with fast-growing biotech based in the Bay Area. They're developing ground b...
  • 6/10/2024 12:00:00 AM

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Clinical Data Manager
  • Actalent
  • Raleigh, NC
  • This large, leading pharmaceutical is looking to hire a fully remote Senior Clinical Data Manager to their team of subje...
  • 6/10/2024 12:00:00 AM

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Sr. Clinical Data Manager
  • Precision Medicine Group
  • Boulder, CO
  • *This position is 100% remote* Position Summary: The Senior Clinical Data Manager is responsible and manages all aspects...
  • 6/10/2024 12:00:00 AM

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Sr. Clinical Data Manager
  • Precision for Medicine
  • Houston, TX
  • *This position is 100% remote* Position Summary: The Senior Clinical Data Manager is responsible and manages all aspects...
  • 6/10/2024 12:00:00 AM

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Sr. Clinical Data Manager
  • Alimentiv
  • Austin, TX
  • JOB SUMMARY: Responsible for leading, planning and execution of all data management activities for assigned projects, en...
  • 6/9/2024 12:00:00 AM

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Clinical Data Manager
  • i-Lumen Scientific, Inc.
  • Minneapolis, MN
  • i-Lumen Scientific is focused on improving day to day life for patients affected with Age-related Macular Degeneration (...
  • 6/8/2024 12:00:00 AM

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Clinical Data Manager
  • Barrington James
  • San Diego, CA
  • We have an exciting new position available for an established biopharmaceutical company onsite in California. (Pasadena ...
  • 6/8/2024 12:00:00 AM

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Clinical Data Manager
  • Birdseye Partners
  • Our client is a leading organization in the antibody driven Immuno-oncology space with a proven platform that has garner...
  • 6/7/2024 12:00:00 AM

California is a state in the Pacific Region of the United States. With 39.6 million residents, California is the most populous U.S. state and the third-largest by area. The state capital is Sacramento. The Greater Los Angeles Area and the San Francisco Bay Area are the nation's second and fifth most populous urban regions, with 18.7 million and 9.7 million residents respectively. Los Angeles is California's most populous city, and the country's second most populous, after New York City. California also has the nation's most populous county, Los Angeles County, and its largest county by area, S...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Data Manager jobs
$124,353 to $154,813

Clinical Data Manager in Sacramento, CA
In the position of a Lead Clinical Data Manager you areĀ in charge of all aspects of the data management process for important projects.
January 06, 2020
Clinical Data Manager in Erie, PA
In order to become a clinical data manager, you will be required to posses a college degree or training certificate in the field of data management.
December 12, 2019
Clinical Data Manager in Anchorage, AK
Most clinical data manager jobs are found in government organizations, pharmaceutical companies, and biotechnology firms.
December 16, 2019