Clinical Research Manager jobs in Wayne, NJ
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
Sr. Clinical Research Liaison
- Pacira BioSciences, Inc.
-
Parsippany, NJ
FULL_TIME
-
About PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.Why work with us?Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.At Pacira Biosciences, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical outcomes.Summary:The Senior Clinical Research Liaison will function as the Lead in the development, monitoring, and completion of clinical registries. This position will be the primary contact with healthcare professionals (HCPs), key opinion leaders (KOLs), as well as the steering committee members and study site staff involved with clinical registries. The individual will provide guidance to study sites to help ensure data capture of high-quality clinical data and estimating project requirements and project coordination. The individual will also collaborate with members of the Medical Science and Clinical Operations team to provide relevant clinical context to studies.Essential Duties & Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
- Understand products, existing literature, registry/study protocols, and therapeutic area in sufficient detail to discuss with HCPs, KOLs, steering committee members and the study site personnel on the technical and clinical aspects of the registries.
- Lead/Attend Site Initiation Visits, Interim Monitoring Visits, and other visits as needed for collaboratives and sponsored studies.
- Conduct site visit, site training and on-site observation. Document the on-site findings, communicate with the study personnel any technical issues identified during the site visit and follow up after the visit to ensure the closure of the issues.
- Actively assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines, and company standard operating procedures.
- Actively participate in study management with the cross functional team (medical directors, clinical operations, safety, data management/statistics and regulatory, etc.).
- Participate in steering committee and site personnel meetings, to ensure the team will achieve key study milestones including timeline and ensure high data quality from the studies assigned.
- Participate in study related document development and review, including study protocols, IRB submissions, and SOPs.
- Develop and maintain relationships with study sites through effective and timely communication.
- Provide support to site investigators and study coordinators to resolve site related issues.
- Maintain a working knowledge of HIPAA, GCP and 21 CFR 812.
- Assist with additional tasks as assigned, including providing clinical context and support for health outcomes studies.
- Maintain credentialling to obtain access to various study sites and operating theatres.
- Monitor and support use of electronic data capture system, with understanding of case report forms and database builds.
- Monitor and support use of Pacira products and clinical applications within research protocols as appropriate.
- Manage budgets and timelines for all registries and hold responsibility for reporting their status.
- Develop and maintain information on registry website.
- Prepare weekly reports on study updates, publications and compile surgical area specific dashboards for reporting to senior management.
Education and Experience:- Bachelor’s or master’s degree in the science/health care field, a nursing degree, or equivalent combined education. Orthopedic experience preferred.
- 7-10 years of clinical/scientific research experience or relevant work in the biosciences industry.
Supervisory Responsibilities:This position does not have supervisory responsibilities.Interaction:The position works closely with the HCPs, KOLs, investigators, site study stuff, clinical operations staff, Medical Science staff and pharmacovigilance/safety staff, to assure the timely and effective support of registries and health outcomes studies.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Knowledge, Skills, and Abilities:- Demonstrated dependability, flexibility, and maturity.
- Positive, even-tempered, and effective in building interpersonal working relationships with various clinical personnel.
- Excellent written and oral English communication and presentation skills.
- Proven ability to work effectively on a team in an entrepreneurial environment.
- Strong organization and documentation skills.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Demonstrated working knowledge of GCP, ICH, and other relevant clinical development regulations and processes are preferred.
Travel Requirement:- Up to 30% travel required
Physical Demands:While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds. This position requires considerable hospital presence and requires the ability to walk and stand for periods of time.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.This position requires considerable on-site presence at clinical trial sites. Ability to function independently using remote office tools.Benefits:- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
- Just Posted
Clinical Research Technician - Photobiology
- Consumer Product Testing Company
-
Fairfield, NJ
FULL_TIME
- The Clinical Research Technician position is based within our Clinical Photobiology department, and works with departmental management and the Principal Investigator in the implementation of Photobiol...
- 2 Months Ago
Oncology/Leukemia Nurse Manager
- Clinical Management Consultants
-
Clifton, NJ
FULL_TIME
- Are you ready to join a prestigious New Jersey hospital's team of professionals as the Oncology/Leukemia Nurse Manager? The Oncology/Leukemia Nurse Manager will join this award winning, teaching hospi...
- 2 Days Ago
RN Manager Oncology
- Clinical Management Consultants
-
Clifton, NJ
FULL_TIME
- Are you ready to join a prestigious New Jersey hospital's team of professionals as the Oncology Nurse Manager? The Oncology Nurse Manager will join this award winning, teaching hospital in New Jersey ...
- 27 Days Ago
Sr-Level Scientist & Project Manager
- Environmental Research Group
-
Wharton, NJ
FULL_TIME
- Sr-Level Scientist / Mid Project Manager Environmental Research Group, LLC incl AmaTerra, ERG Texas Services. Founded in 2000, ERG is an environmental consulting small business providing National Envi...
- 14 Days Ago
Medical Affairs Associate Project Manager : HYBRID, NJ
- Maxis Clinical Sciences
-
Nutley, NJ
CONTRACTOR
- 3 days onsite/week The Medical Affairs Strategic Planning & Operations Team is looking for the right candidate to dive right in and get down to business. You have initiative and are able to identify a...
- 4 Days Ago
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0 Clinical Research Manager jobs found in Wayne, NJ area
Sr. Clinical Study Manager
- Kedrion Biopharma, Inc.
-
Fort Lee, NJ
- Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-...
- 5/4/2024 12:00:00 AM
Project Coordinator
- Collabera
-
Rahway, NJ
- Description Home Search Jobs Job Description Project Coordinator Contract: Rahway, New Jersey, US Salary: $33.00 Per Hou...
- 5/4/2024 12:00:00 AM
Associate Director - IT Clinical Research Systems (1112975_RR00077161)
- NYU Langone Medical Center
-
New York, NY
- NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of...
- 5/2/2024 12:00:00 AM
Clinical Research Finance Analyst. (1126460_RR00089956)
- NYU Langone Medical Center
-
New York, NY
- NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of...
- 5/2/2024 12:00:00 AM
Clinical Research Coordinator II-WBRI-32082-004
- Mount Sinai Hospital
-
New York, NY
- Job Description Under minimal supervision, coordinates the clinical assessments of the study subjects; analyzes and assi...
- 5/2/2024 12:00:00 AM
Senior Clinical Research Program Manager
- Northwell Health
-
New Hyde Park, NY
- Job Description Job Description Provides management of research administration at a clinical site(s) including monitorin...
- 5/1/2024 12:00:00 AM
Senior Clinical Research Program Manager
- Northwell Health
-
Great Neck, NY
- Job Description Provides management of research administration at a clinical site(s) including monitoring the quality an...
- 5/1/2024 12:00:00 AM
Clinical Research Manager
- Colgate-Palmolive
-
Piscataway, NJ
- No Relocation Assistance Offered # 159181 - Piscataway, New Jersey, United States **Who We Are** Colgate-Palmolive Compa...
- 4/30/2024 12:00:00 AM
About Wayne, New Jersey
Wayne is a township in Passaic County, New Jersey, United States located less than 20 miles (32 km) from Midtown Manhattan, and is home to William Paterson University. As of the 2010 United States Census, the township had a total population of 54,717, reflecting an increase of 648 (+1.2%) from the 54,069 counted in the 2000 Census, which had in turn increased by 7,044 (+15.0%) from the 47,025 counted in the 1990 Census.
Wayne was formed as a township by an act of the New Jersey Legislature on April 12, 1847, from portions of Manchester Township. Totowa was formed from portions of Wayne and Man...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$114,510 to $151,711
Wayne, New Jersey area prices
were up 1.5% from a year ago
were up 1.5% from a year ago
What does a Clinical Research Manager do?
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