Clinical Research Manager jobs in Fishers, IN

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 - Indianapolis, IN (Remote-Regional)
  • Pharmaceutical Research Associates, Inc
  • Indianapolis, IN OTHER
  • Overview

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

    Responsibilities

    What will you be doing?

    • Works on multiple trials across multiple Therapeutic Areas
    • Quality of life focus wtih Regional Travel
    • Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team
    • Acts as Lead SM-training other SMs on study
    • Develops site start up documents for studies including SIV agenda
    • Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
    • Represents LTMs or SMs on SMTs/meetings 
    • Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
    • Supports country budget development and/or contract negotiation in liaison with CCS colleagues
    • Assists with ASV
    • Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

     

    Interfaces – Primary/Other:

        • Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
        • Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)

    Qualifications

    What do you need to have?

    • Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
    • Must be located in Indianapolis, IN area as this position is regional
    • Have a minimum of 1 - 3 years’ experience in monitoring pharmaceutical industry clinical trials
    • Knowledge of several therapeutic areas
    • Analytical/risk-based monitoring experience is an asset
    • Ability to actively drive patient recruitment strategies at assigned sites
    • Ability to partner closely with investigator and site staff to meet all of our study timelines
    • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
    • Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face.  Strong team member and self-starter with the ability to work independently.
    • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
    • Need to travel up to 50%
    • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

    What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

    • Various annual leave entitlements
    • A range of health insurance offerings to suit you and your family’s needs
    • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
    • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
    • Life assurance
    • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

    Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

  • 2 Months Ago

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Clinical Research Nurse - Oncology
  • C0001 Franciscan Health Indianapolis
  • Indianapolis, IN FULL_TIME
  • Franciscan Health Indianapolis Campus 8111 South Emerson Avenue Indianapolis, Indiana 46237 WHO WE ARE With 12 ministries and access points across Indiana and Illinois, Franciscan Health is one of the...
  • 19 Days Ago

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Clinical Research Coordinator
  • C0001 Franciscan Health Indianapolis
  • Indianapolis, IN FULL_TIME
  • Franciscan Health Indianapolis Campus 8111 South Emerson Avenue Indianapolis, Indiana 46237 WHO WE ARE With 12 ministries and access points across Indiana and Illinois, Franciscan Health is one of the...
  • 19 Days Ago

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Senior Clinical Research Coordinator
  • Actalent
  • Indianapolis, IN OTHER
  • The Sr. Clinical Research Coordinator is responsible for independently running and operating multiple research protocols in conjunction with the Principal Investigator and serves as a lead in the clin...
  • Just Posted

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Clinical Research Nurse
  • Actalent
  • Indianapolis, IN OTHER
  • Great Opportunity to Join a Growing Team!Long-Term OpportunityCompetitive PayRequired:1 years of Clinical Research Nursing experience or 2 years of Registered Nursing experienceNeurology Clinical Tria...
  • 7 Days Ago

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Mobile Clinical Research Nurse
  • ViTalent
  • Zionsville, IN FULL_TIME
  • DescriptionWe are looking for a per diem Registered Nurse (RN) to join our Clinical Research Team.Must have strong phlebotomy experience. Skillset includes cannulation, infusions and strong venipunctu...
  • 9 Days Ago

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0 Clinical Research Manager jobs found in Fishers, IN area

Fishers is a city in Fall Creek and Delaware townships, Hamilton County, Indiana, United States. As of the 2010 census the population was 76,794, and by 2017 the estimated population was 91,832. A suburb of Indianapolis, Fishers has grown rapidly in recent decades: about 350 people lived there in 1963, 2,000 in 1980, and only 7,500 as recently as 1990. After the passage of a referendum on Fishers' status in 2012, Fishers transitioned from a town to a city on January 1, 2015. The first mayor of Fishers—Scott Fadness—along with the city's first clerk and city council were sworn in on December 21...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$94,587 to $125,321
Fishers, Indiana area prices
were up 1.3% 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