Clinical Research Manager jobs in Hayward, 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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Clinical Research Associate II
  • Advanced Clinical
  • Alameda, CA FULL_TIME
  • OVERVIEW
    We are currently searching for a skilled professional to join a well-known client's team as a Clinical Research Associate II in Alameda, CA. The Clinical Research Associate II will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.


    RESPONSIBILITIES
    The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
    * Conduct single or multi-center medical device clinical studies.
    * Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.
    * Participate in study start up activities.
    * Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.
    * Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
    * Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
    * Maintain and audit Trial Master File to ensure inspection readiness.
    * Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed*
    * Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
    * Proactively and effectively communicate the status of clinical studies to management.
    * Ensures quality delivery of study deliverables within agreed budgets and timelines.
    * Participate in the interim and final reviews of study data in preparation of regulatory submissions.
    * Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
    * May interact with RA/QA in responding to audits and FDA inquiries.

    EDUCATION
    * BS degree in life sciences or equivalent with minimum 5 years of related experience, or MS degree in life sciences or equivalent with minimum 3 years of experience, or PhD with 2 years of experience.

    EXPERIENCE
    * Must have 5 years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations.
    * Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.

    To be a best-fit your strengths must include:
    * Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
    * Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
    * Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
    * Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
    * Working knowledge of GCP, Clinical and Regulatory Affairs.
    * Flexibility in daily activities.
    * Proficient with Microsoft Suite.

    Travel Requirements

    * Must be able to travel 30-50%


    About Advanced Clinical

    Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

    Regarding your application
    Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

    It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

  • 1 Month Ago

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Psychological Clinical Trial Rater
  • Sunwise Clinical Research
  • Lafayette, CA PART_TIME,CONTRACTOR
  • Full Job Description Looking for a Clinical Psychology Professional will administer psychological efficacy scales, conduct interviews, adhere to study protocols and who will bring excellent patient ca...
  • 12 Days Ago

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Clinical Trial Research Nurse Manager
  • Kaiser
  • Castro Valley, CA FULL_TIME
  • Job Summary: The Clinical Trial Nurse Manager (CTN-Manager) position assists in the administrative leadership and direction of the operational aspects of a large and/or multiple regional clinical tria...
  • Just Posted

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Clinical Trial Research Nurse Manager
  • Kaiser
  • Moraga, CA FULL_TIME
  • Job Summary: The Clinical Trial Nurse Manager (CTN-Manager) position assists in the administrative leadership and direction of the operational aspects of a large and/or multiple regional clinical tria...
  • Just Posted

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Senior Clinical Research Scientist
  • Caribou Biosciences, Inc.
  • Berkeley, CA FULL_TIME
  • Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-genera...
  • 22 Days Ago

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Clinical Research Associate
  • Codetru
  • Alameda, CA CONTRACTOR,FULL_TIME
  • Job Summary:We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. The Clinical Research Associate will be responsible for assisting in the coordination an...
  • Just Posted

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0 Clinical Research Manager jobs found in Hayward, CA area

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Principal Biostatistician (Remote)
  • Freenome
  • South San Francisco, CA
  • Why join Freenome? Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood dr...
  • 3/28/2024 12:00:00 AM

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Clinical Project Manager
  • SciPro
  • Hayward, CA
  • SciPro is working alongside the Clinical Development Operations Leadership team for an exciting oncology company. The bi...
  • 3/28/2024 12:00:00 AM

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Clinical Research Coordinator
  • The University of California, San Francisco
  • San Francisco, CA
  • The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator (CRC) to join th...
  • 3/27/2024 12:00:00 AM

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Cancer Clinical Research Coordinator Associate Neuro Oncology
  • Stanford University
  • Stanford, CA
  • Cancer Clinical Research Coordinator Associate Neuro-Oncology The Stanford Cancer Institute (SCI) is one of an elite num...
  • 3/25/2024 12:00:00 AM

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Cancer Clinical Research Coordinator Associate Pediatric Oncology (Hybrid)
  • Stanford University
  • Stanford, CA
  • Cancer Clinical Research Coordinator Associate Pediatric Oncology (Hybrid) The Stanford Cancer Institute (SCI) is one of...
  • 3/25/2024 12:00:00 AM

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Clinical Research Coordinator Associate (Autopsy/Clinical)
  • Stanford University
  • Stanford, CA
  • Clinical Research Coordinator for Cognitive Aging Studies Do you want to help Stanford University develop world-leading ...
  • 3/25/2024 12:00:00 AM

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Senior Clinical Program Manager, Clinical Operations Study Management
  • Eikon Therapeutics, Inc.
  • Hayward, CA
  • Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistr...
  • 3/24/2024 12:00:00 AM

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Nurse Manager of Trauma Program
  • Clinical Management Consultants
  • Ross, CA
  • A fantastic career opportunity for Nurse Manager of Trauma Program is now available with a growing and financially stabl...
  • 3/24/2024 12:00:00 AM

Hayward (/ˈheɪwərd/; formerly Haywards, Haywards Station, and Haywood) is a city located in Alameda County, California in the East Bay subregion of the San Francisco Bay Area. With a 2014 population of 149,392, Hayward is the sixth largest city in the Bay Area and the third largest in Alameda County. Hayward was ranked as the 37th most populous municipality in California. It is included in the San Francisco–Oakland–Fremont Metropolitan Statistical Area by the US Census. It is located primarily between Castro Valley and Union City, and lies at the eastern terminus of the San Mateo–Hayward Bridg...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$120,576 to $159,755
Hayward, California area prices
were up 4.5% from a year ago

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