Clinical Research Manager jobs in Ventura, CA

Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Sr. Associate Manager, Clinical Research (CONTRACT TO HIRE)
  • MannKind Corporation
  • Westlake, CA FULL_TIME
  • At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

    MannKind Corporation is currently seeking a Sr. Associate Manager, Clinical Research. This role is an integral member of the clinical operations team, supporting strategic planning for Phase 1 through 4 clinical trials to ensure the safety and effectiveness of MannKind products. Specific activities include contributing to clinical trial plans, various aspects of clinical trial operations in collaboration with Clinical Research Organizations (CRO) and other external parties, study recruitment efforts and data analysis.

    The Sr. Associate Manager, Clinical Research provides technical and administrative support for multiple studies and must ensure that all activities are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), and Good Clinical Practices (GCPs). This position is contract to direct hire.

    Essential Duties and Job Functions:
    • Assists with the development and management of study related documents including clinical protocols, case report forms, study manuals, operational plans, recruitment content, and other study materials.
    • Ensures readiness of study supplies, study tools, devices, and investigational products (IP) for use in clinical trials.
    • Tracks and reports progress of studies including site certifications, subject enrollment, data collection, documentation of adverse events, and real-time study data
    • Creates and maintains registry postings, such as clintrials.gov
    • Initiates contracts and provides operational oversight of vendors and other external third parties such as patient advocacy groups and CROs
    • Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for study related meetings
    • Maintains relationships and addresses questions regarding procedural issues from clinical sites and helps identify areas of improvement
    • Assists in the identification and assessment of clinical sites for study participation
    • Supports site certification procedures including Investigator Meeting and Site Initiation Meeting planning, and preparation and presentation of training materials
    • Manages and maintains study Trial Master Files (TMF), including scheduled reconciliation, and escalates any issues to study leads
    • Assists in the preparation and review of regulatory documents (for example IND annual reports, safety reports, Investigator Brochures, etc.)
    • Supports data analysis, research, and scientific exchange through statistical analysis, literature research, and scientific publication
    • Contributes to process improvement initiatives, SOP development, and document revisions
    Knowledge, Experience and Skills:
    • Requires a four-year degree (in biological, physical, engineering sciences or related discipline) and related experience in clinical operations such as in a pharmaceutical, medical device, research, or academic
      • 3 years of relevant clinical operations experience directly supporting clinical study conduct
      • 1 years of relevant clinical operations experience directly supporting clinical study conduct with a MS degree
      • No additional experience with a PharmD degree
    • Requires excellent verbal and written communication skills and interpersonal skills to build/maintain strong relationships with clinical sites, vendors, patient advocacy groups and internal team
    • Demonstrated ability to be a fast learner, with strong attention to detail
    • Demonstrated ability to solve problems and manage multiple tasks
    • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
    • Demonstrated ability to analyze and interpret data and communicate conclusions clearly and concisely
    • Demonstrated ability to work effectively within multidisciplinary teams
    • Proficient in Microsoft Office products (Word, Excel, PowerPoint, etc.), including SharePoint and other collaboration tools.
    • Knowledge of GCP and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA) preferred
    • Knowledge and experience with diabetes and/or orphan lung therapeutic area preferred

  • 6 Days Ago

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Clinical Research Operations Internship
  • MannKind Corporation
  • Westlake, CA FULL_TIME
  • Internship Overview: Clinical Operations Intern We are seeking a highly motivated and detail-oriented Clinical Operations Intern to join our team. This internship will provide invaluable hands-on expe...
  • 2 Days Ago

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Clinical Research Assistant
  • Care Access
  • Thousand Oaks, CA FULL_TIME
  • What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physici...
  • 12 Days Ago

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Clinical Research Operations Internship
  • Mannkind Corporation
  • Westlake, CA FULL_TIME
  • Position: Clinical Research Operations Internship Location: Westlake Village, CA Job Id: 11056 # of Openings: 1 Internship Overview: Clinical Operations Intern We are seeking a highly motivated and de...
  • 2 Months Ago

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Territory Account Manager
  • Syneos Health Clinical
  • Thousand Oaks, CA FULL_TIME
  • Description You have what it takes: a competitive drive coupled with exceptional sales ability. In this role, you will implement the sales plan by delivering proficient sales presentations to a define...
  • 12 Days Ago

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Clinical Research Coordinator, Westlake Village
  • University of California - Los Angeles Health
  • Westlake, CA FULL_TIME
  • DescriptionThe Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. In this role,...
  • 12 Days Ago

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0 Clinical Research Manager jobs found in Ventura, CA area

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Medical Assistant
  • California Retina Consultants
  • Santa Barbara, CA
  • OphthalmicTechnician (Medical Assistant) As an Ophthalmic Technician you will preform a number of pre-exam diagnostic te...
  • 4/26/2024 12:00:00 AM

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Principal Scientist
  • Bausch + Lomb
  • Ventura, CA
  • Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of ...
  • 4/26/2024 12:00:00 AM

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Ophthalmic Technician
  • California Retina Consultants
  • Santa Barbara, CA
  • OphthalmicTechnician (Medical Assistant) As an Ophthalmic Technician you will preform a number of pre-exam diagnostic te...
  • 4/26/2024 12:00:00 AM

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Senior Principal Scientist - Medicinal Chemistry
  • Amgen
  • Thousand Oaks, CA
  • **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like youre part of something bigger, its because you are. At Amgen, our ...
  • 4/26/2024 12:00:00 AM

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Principal Scientist
  • Bausch + Lomb
  • Thousand Oaks, CA
  • Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of ...
  • 4/26/2024 12:00:00 AM

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Principal Scientist
  • Bausch + Lomb
  • Santa Barbara, CA
  • Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of ...
  • 4/26/2024 12:00:00 AM

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Observational Research Manager
  • Amgen
  • Thousand Oaks, CA
  • **HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take...
  • 4/25/2024 12:00:00 AM

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Licensed Therapist
  • Pinnacle Treatment Centers
  • Ventura, CA
  • Overview: We offer competitive salary, full benefits package, Paid Time Off, and opportunities for professional growth. ...
  • 4/23/2024 12:00:00 AM

Ventura is located northwest of Los Angeles on the California coast. The western portion of the city stretches north along the Ventura River and is characterized by a narrow valley with steeply sloped areas along both sides. The steep slopes of the Ventura foothills abut the northern portion of the community. Much of the eastern portion is on a relatively flat alluvial coastal plain lying along the western edge of the Oxnard Plain. The Santa Clara River forms the city's southerly boundary with the city limits reaching up to the beginning of the Santa Clara River Valley at the historic communit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$106,377 to $140,942
Ventura, California area prices
were up 2.5% from a year ago

Clinical Research Manager in Springfield, IL
Generally, employers are looking for Clinical Research Managers who have a Bachelors degree.
December 10, 2019
Clinical Research Manager in Colorado Springs, CO
We ranked the top skills based on the percentage of Clinical Research Manager resumes they appeared on.
November 28, 2019
Clinical Research Manager in Little Rock, AR
In this requirements guide for Clinical Research Coordinators, you will find out what do you need to become a Clinical Research Coordinator and what it takes to become one.
January 12, 2020