Clinical Research Manager jobs in North Carolina

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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Project Manager, Clinical Operations
  • Velocity Clinical Research, Inc.
  • Durham, NC FULL_TIME
  • Overview

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

     

    As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

     

    Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

     

    Job Summary:

    The Clinical Operations Project Manager will be responsible for the planning, execution, and oversight of clinical trials and projects to ensure they are completed on time, within budget, and in compliance with regulatory requirements.

    Responsibilities

    Duties/Responsibilities:

    • Develop and maintain project plans, timelines, and budgets for assigned clinical trials and projects.
    • Coordinate with cross-functional teams including Clinical Research, Regulatory Affairs, Data Management, and Quality Assurance to ensure alignment on project goals and objectives.
    • Identify potential risks and issues and develop mitigation strategies to ensure successful project execution.
    • Select, negotiate contracts with, and oversee third-party vendors and service providers involved in clinical trial activities, such as Contract Research Organizations (CROs), central laboratories, and clinical sites.
    • Monitor vendor performance and adherence to contractual agreements, and address any issues or concerns in a timely manner.
    • Ensure compliance with relevant regulatory requirements, including Good Clinical Practice (GCP) guidelines, and local regulations.
    • Collaborate with Regulatory Affairs to prepare and submit regulatory documents and filings as necessary.
    • Coordinate and allocate internal and external resources effectively to support clinical trial activities.
    • Manage study budgets, track expenses, and provide regular financial updates to stakeholders.
    • Serve as the primary point of contact for internal and external stakeholders regarding project status, progress, and issues.
    • Prepare and present project updates, reports, and presentations to senior management and project teams as needed.

     

    Required Skills/Abilities:

    • Strong understanding of clinical trial conduct, regulations, and guidelines.
    • Excellent organizational, problem-solving, and decision-making skills.
    • Proven ability to manage multiple projects simultaneously and prioritize tasks effectively.
    • Strong interpersonal and communication skills, with the ability to work collaboratively in a cross-functional team environment.
    • Proficiency in project management software/tools and Microsoft Office suite.
    • PMP or other relevant certifications are a plus.

    Qualifications

    Education and Experience:

    • Bachelor's degree in life sciences, pharmacy, nursing, or related field; advanced degree preferred.
    • Minimum of 5 years of experience in clinical operations/project management in the pharmaceutical, biotechnology, or medical device industry.

     

    NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required.  Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change.  All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

  • 13 Days Ago

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Manager, Clinical Monitoring
  • Catalyst Clinical Research LLC
  • Wilmington, NC FULL_TIME
  • Catalyst Clinical Research is a niche provider of clinical research services through two established solutions- Catalyst Flex and Catalyst Oncology. Here at Catalyst Clinical Research we provide suppo...
  • 1 Month Ago

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Manager, Revenue
  • Velocity Clinical Research, Inc.
  • Durham, NC FULL_TIME
  • Overview Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we ...
  • 25 Days Ago

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Manager, Feasibility
  • Velocity Clinical Research, Inc.
  • Durham, NC FULL_TIME
  • Overview Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we ...
  • 1 Month Ago

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Clinical Research Assistant
  • Velocity Clinical Research, Inc.
  • Durham, NC FULL_TIME
  • Overview Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we ...
  • 22 Days Ago

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Clinical Research Manager
  • OHSU
  • Portland, OR
  • Department Overview The Clinical Research Manager for the Hypertrophic Cardiomyopathy (HCM) and Amyloid Clinical Researc...
  • 3/28/2024 12:00:00 AM

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Clinical Research Manager - Research Associate 5
  • Louisiana State University
  • Baton Rouge, LA
  • All Job Postings will close at 12:01a.m. CST (1:01a.m. EST) on the specified Closing Date (if designated). If you close ...
  • 3/28/2024 12:00:00 AM

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Clinical Research Manager I (Orthopedics - Sports Medicine) Waltham
  • Boston Childrens Hospital
  • Waltham, MA
  • Job Posting Description The department of Orthopedics and Sports Medicine is host to the Clinical Effectiveness Research...
  • 3/28/2024 12:00:00 AM

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Clinical Research Manager (Ophthalmology)
  • Northwestern University
  • Chicago, IL
  • Department: MED-Ophthalmology Salary/Grade: EXS/7 Job Summary: Oversees the Department of Ophthalmology research program...
  • 3/27/2024 12:00:00 AM

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Clinical Study Manager
  • Element Materials Technology
  • Louisville, CO
  • Overview: Element has a current opening for a Clinical Study Manager to join our growing team in Colorado. Our Clinical ...
  • 3/25/2024 12:00:00 AM

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Sr. Clinical Study Manager
  • Haleon Plc.
  • Warren, NJ
  • Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving e...
  • 3/25/2024 12:00:00 AM

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Senior Clinical Study Manager
  • ANAPTYSBIO INC
  • San Diego, CA
  • Position Summary This position is accountable for all operational activities related to planning, executing/conducting a...
  • 3/25/2024 12:00:00 AM

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Manager, Clinical Research Budgets/Contracts
  • Hackensack Meridian Health
  • Eastchester, NY
  • Description: Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients ...
  • 3/25/2024 12:00:00 AM

North Carolina (/ˌkærəˈlaɪnə/ (listen)) is a state in the southeastern region of the United States. It borders South Carolina and Georgia to the south, Tennessee to the west, Virginia to the north, and the Atlantic Ocean to the east. North Carolina is the 28th-most extensive and the 9th-most populous of the U.S. states. The state is divided into 100 counties. The capital is Raleigh, which along with Durham and Chapel Hill is home to the largest research park in the United States (Research Triangle Park). The most populous municipality is Charlotte, which is the second-largest banking center in...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$95,036 to $125,916

Clinical Research Manager in Richland, WA
Clinical research managers must plan every phase of research programs, from initial concept through product development and clinical trials to submission for approval by the U.S.
November 27, 2019
Clinical Research Manager in Spartanburg, SC
Research is both the foundation and the future of medicine.
December 17, 2019
Clinical Research Manager in Vallejo, CA
When transitioning into the clinical research field from a science background, it is good to know what experience you have, what positions you are interested in, and what careers are most appropriate for your background.
December 19, 2019