Clinical Data Manager jobs in Chula Vista, CA

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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Senior Clinical Data Manager
  • Artiva Biotherapeutics
  • San Diego, CA FULL_TIME
  • About Artiva:

    Artiva Biotherapeutics is a cell therapy company with a “Manufacturing-First” strategy. We developed our manufacturing platform to advance highly scaled, off-the-shelf, allogeneic natural killer (NK) cell therapies for outpatient administration in the treatment of cancer and autoimmune diseases. Our pipeline comprises both highly active non-genetically modified NK cell and CAR-NK cell therapies. Our non-genetically modified NK cells can be used as antibody-dependent cellular cytotoxicity (ADCC) enhancers in patients undergoing monoclonal antibody therapy. Our genetically modified CAR-NK cell therapies leverage the innate biology and safety features of NK cells, while enhancing their efficacy with chimeric antigen receptors (CARs). Artiva solves many of the previous challenges in cell therapy to deliver potentially life-saving treatments with safe, effective, scalable, versatile, and cost-effective NK cell products. Artiva is headquartered in San Diego.


    Job Summary:

    Artiva Biotherapeutics is seeking an experienced Senior Clinical Data Manger who will report to the Associate Director of Clinical Data Management, or higher.  This role will be responsible for Data Management activities from study start-up to close-out.  This person will work closely with key functional areas and external vendors to lead and oversee clinical data management activities and ensure the timely and successful delivery of high-quality data.  Functional areas include, but are not limited to Clinical Operations, Clinical Development, Statistics, Translational Sciences, Program Management, Regulatory, Finance and Legal.

     

    Duties/Responsibilities:

    • Review and approve Data Management documents
    • Coordinate and lead Artiva Unit Acceptance Testing (UAT) activities
    • Participate in development of project level timelines
    • Coordinate and lead Artiva data quality reviews
    • Review and provide feedback to clinical team on other study documents e.g., Statistical Analysis Plan, Monitoring Plan
    • Participate in regular study and project team meetings
    • Provide oversight of Data Management activities performed by Clinical Research Organization (CRO) to include, but not limited to:
        • Electronic Data Capture (EDC) system development and modifications
        • Development of Data Management documents e.g., Case Report Forms, Data Management Plan, build and validation specifications
        • Development and management of Data Management timelines
        • Serious Adverse Event (SAE) and third-party data reconciliations
        • Development of third-party Data Transfer Agreements (DTAs)
        • CRO quality Data Management deliverables e.g., Metrics, extracts, reports
        • Database soft and hard lock activities


    Requirements:

    • Minimum 5-8 years of pharmaceutical, biotech or CRO industry experience
    • Track record of managing and overseeing Data Management activities directly or through CRO and third-party service providers
    • Extensive knowledge of data management documents e.g., CRFs, DMP, specifications
    • Understanding of applicable regulatory guidelines and industry standards e.g., ICH GCP and FDA guidelines, 21 CFR 11
    • Extensive knowledge of EDC systems e.g., Medidata Rave, Medrio
    • Knowledge of cell therapy in oncology or autoimmune therapeutic areas preferred
    • Bachelor’s degree in science, computer science, or related field preferred
    • Working knowledge of Microsoft tools e.g., SharePoint, Word, Excel
    • Strong written, verbal, and interpersonal communication skills


    Why you should apply:

    We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.  We are innovative - pushing into new frontiers for patient benefit.  We are transparent - believers in flat, accessible, and open communication paths.  We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.


    In addition to a great culture, we offer:

    · A beautiful facility 

    · An entrepreneurial, highly collaborative, and innovative environment

    · Comprehensive benefits, including:

    • Medical, Dental, and Vision
    • Group Life Insurance
    • Long Term Disability (LTD)
    • 401(k) Retirement Plan
    • Employee Assistance Program (EAP)
    • Flexible Spending Account (FSA)
    • Paid Time Off (PTO)
    • Company paid holidays, including the year-end holiday week
    • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.


    If all this speaks to you, come join us on our journey!

     

    Artiva Biotherapeutics is an equal employment opportunity employer.


    Base Salary: $126,000 - 164,000 . Exact compensation may vary based on skills and experience.

  • 23 Days Ago

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Sr Clinical Data Manager
  • Genesis10
  • San Diego, CA FULL_TIME
  • Genesis10 is seeking a Sr Clinical Data Manager for a leading company in San Diego, CA. This REMOTE 6-month contract role pays $55-60/HR W2 based on experience. Job Description: Responsible for data m...
  • Just Posted

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Senior Clinical Data Manager
  • Allen Spolden
  • Escondido, CA FULL_TIME
  • The Clinical Data Manager manages the general conduct of project assigned tasks as the Lead Data Manager or under advisement from senior members of the Data Management Team. Responsible for oversight ...
  • 17 Days Ago

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Senior Clinical Data Manager (Remote)
  • Jazz Pharmaceuticals
  • Carlsbad, CA FULL_TIME
  • Overview If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform th...
  • 1 Month Ago

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Clinical Services Liaison
  • Physicians Data Trust
  • Vista, CA FULL_TIME
  • Clinical Services Liaison Department: Clinical Services Effective Date: October 11, 2021 Reports to: Clinical Services Manager Direct Reports: None FLSA: Non-Exempt Working Conditions: Normal, no adve...
  • 1 Month Ago

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Senior Manager, Clinical Data Management - REMOTE
  • Proclinical Staffing
  • San Diego, CA FULL_TIME
  • Senior Manager, Clinical Data Management - Permanent - Remote Proclinical Staffing is seeking a Senior Manager, Clinical Data Management to join a cutting-edge biotech company. This is a permanent rol...
  • Just Posted

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0 Clinical Data Manager jobs found in Chula Vista, CA area

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Care Worker- Must Reside in California
  • Magellan Health, Inc.
  • San Diego, CA
  • Facilitates department workflow by supporting clinical team with administrative care coordination support. Locates commu...
  • 3/29/2024 12:00:00 AM

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Research Nurse Pract/ Physician Assistant
  • ProSciento, Inc
  • Chula Vista, CA
  • Job Description Job Description Exact compensation may vary based on skills, experience, and location. Summary: With phy...
  • 3/29/2024 12:00:00 AM

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Director, Clinical Pharmacology
  • Inmagene Biopharmaceuticals
  • San Diego, CA
  • Summary Of Key Responsibilities Responsible for leading all clinical pharmacology activities in support of Inmagene deve...
  • 3/29/2024 12:00:00 AM

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Phlebotomist
  • La Maestra Community Health Centers
  • San Diego, CA
  • Job Description Job Description Pay Range: $21.00 to $29.94 per hour, Depends on Experience (DOE) The Phlebotomist is re...
  • 3/29/2024 12:00:00 AM

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Research Physician II - Infectious Disease
  • The Henry M. Jackson Foundation for the Advancement of Military Medicine
  • San Diego, CA
  • Join the HJF Team! HJF is seeking a Research Physician II to provide scientific, technical, and programmatic support ser...
  • 3/28/2024 12:00:00 AM

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Sr Clinical Data Manager
  • Genesis Corp./New Journey AI LLC
  • San Diego, CA
  • Genesis10 is seeking a Sr Clinical Data Manager for a leading company in San Diego, CA. This REMOTE 6-month contract rol...
  • 3/27/2024 12:00:00 AM

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Research Nurse Pract/ Physician Assistant
  • ProSciento, Inc
  • Chula Vista, CA
  • Job Description Job Description Exact compensation may vary based on skills, experience, and location. Summary: With phy...
  • 3/26/2024 12:00:00 AM

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X-Ray Tech and Medical Assistant
  • Akeso Occupational Health
  • San Diego, CA
  • Job Type Full-time Description Perform radiological duties in compliance with x-ray department and legal requirements. H...
  • 3/25/2024 12:00:00 AM

Chula Vista (/ˌtʃuːlə ˈvɪstə/; English: beautiful view ) is the second largest city in the San Diego metropolitan area, the seventh largest city in Southern California, the fourteenth largest city in the state of California, and the 74th-largest city in the United States. The population was 243,916 as of the 2010 census. Located just 7.5 miles (12.1 km) from downtown San Diego and 7.5 miles (12.1 km) from the Mexican border in the South Bay region of the metropolitan area, the city is at the center of one of the richest economic and culturally diverse zones in the United States. Chula Vista is...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Data Manager jobs
$120,976 to $150,616
Chula Vista, California area prices
were up 2.6% from a year ago

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