Clinical Research Manager jobs in the United States
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)
Recently Added Clinical Research Manager jobs
Clinical Research Site Manager
- DM Clinical Research
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Tomball, TX
FULL_TIME
-
Clinical Research Site ManagerThe Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. Also To ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES- Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
- Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations.
- Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
- Sponsor-provided and IRB-approved Protocol Training
- All relevant Protocol Amendments Training
- Any study-specific Manuals Training as applicable
- Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
- It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study.
- Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites.
- Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s).
- Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents.
- Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
- Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations
- Coaching, counseling, and disciplining the employees as applicable.
- To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
- Communicating and effective implementation of strategic goals from senior management to the site team.
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
- Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s).
- Being prepared for and available at all required company meetings.
- Submitting required administrative paperwork per company timelines.
- Occasionally attending out-of-town Investigator Meetings.
- Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCEEducation:- Bachelor’s degree preferred
- Advanced degree preferred
Experience:- At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization.
Credentials:- Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.
Knowledge and Skills:- Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail.
- Critical Thinking
- Active Listening
- Reading Comprehension — Understanding written sentences and paragraphs in work-related documents.
- Speaking and Writing to communicate effectively as appropriate for the needs of the audience.
- Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.
- Strong computer skills in relevant software and related clinical systems are required.
- Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
- 10 Days Ago
Clinical Research Site Manager
- DM Clinical Research
-
Humble, TX
FULL_TIME
- Clinical Research Site ManagerDepartmentClinical Operations - HumbleEmployment TypeFull-TimeMinimum ExperienceSenior Manager/SupervisorDM Clinical Research, the largest privately-owned research manage...
- 2 Days Ago
Clinical Research Site Manager
- Segal Institute for Clinical Research
-
Miami, FL
FULL_TIME
- The Research Site Manager is responsible for directly overseeing day-to-day clinical operations at Miami Lakes Medical Research, including organization and implementation of all aspects of daily clini...
- 29 Days Ago
Clinical Research Site Manager
- DM Clinical Research
-
Sugar Land, TX
FULL_TIME
- Clinical Research Site ManagerDepartmentClinical Operations - Sugar LandEmployment TypeFull-TimeMinimum ExperienceSenior Manager/SupervisorDM Clinical Research, the largest privately-owned research ma...
- 1 Month Ago
Clinical Research Site Operations Manager
- DM Clinical Research
-
Tomball, TX
FULL_TIME
- Clinical Research Site Operations ManagerThe Site Operations Manager will work as a Site Director to ensure study enrollment meet or exceed Sponsors' expectations, and company goals are achieved on a ...
- Just Posted
Manager, Clinical Protocol Administration - Clinical Research
- Clinical Research - MD Anderson Cancer Center Careers
-
United States, TX
FULL_TIME
- The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and pr...
- 6 Days Ago
Clinical Research Manager jobs at Popular Companies
Clinical Research Assistant (HS)
- The Ohio State University
-
Columbus, OH
- Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessiblea...
- 4/19/2024 12:00:00 AM
Project Manager - Life Science Research (OH or Remote Eastern US)
- Battelle Memorial Institute
-
Columbus, OH
- Battelle delivers when others cant. We conduct research and development, manage national laboratories, design and manufa...
- 4/19/2024 12:00:00 AM
Clinical Research Monitor, Midwest Region THV
- Edwards Lifesciences
-
Columbus, OH
- Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate...
- 4/19/2024 12:00:00 AM
Post Doctoral Scientist - Digital Health Applications
- Nationwide Children's Hospital
-
Columbus, OH
- Dr. Micah Skeens Research Program We are inviting applications for a funded postdoctoral scholar to join Dr. Micah Skeen...
- 4/19/2024 12:00:00 AM
Medical Science Liaison - Ohio/PA Market
- Exact Sciences
-
Columbus, OH
- Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for ca...
- 4/18/2024 12:00:00 AM
Research Associate 1, Clinical and Translational Research - Townsend Lab
- The Ohio State University
-
Columbus, OH
- Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessiblea...
- 4/18/2024 12:00:00 AM
Research Associate
- AstrixTechnology LLC
-
Columbus, OH
- Job Description Job Description Research Associate Our client is working to develop excellent genetic therapy to treat d...
- 4/18/2024 12:00:00 AM
Medical Science Liaison Onc Prostate Radioligand Therapies OH Remote
- Novartis AG
-
Columbus, OH
- About the Role This position focuses on disease states (e.g. prostate cancer, neuroendocrine tumors, & etc.) being treat...
- 4/17/2024 12:00:00 AM
Income Estimation for Clinical Research Manager jobs
$99,232 to $131,475