Clinical Research Manager jobs in Irvington, 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)

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Clinical Research Manager
  • Tekskills Inc
  • East Hanover, NJ CONTRACTOR
  • Job Title : Clinical Research Manager

    Location : East Hanover, NJ ( Hybrid )

    Duration : 12 Months

    Must have : Pharma background is must, clinical research experience, drug development experience, GCP

    Description

    The Clinical Development Director is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), and/ or indication related clinical trial(s), under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase)

    Major Activities

    • Provides clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols or substudies consistent with the Integrated Development Plans (IDP), clincal data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
    • Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
    • Drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates, if applicable
    • May be the Program Manager of other associates (e.g., CTH, CSE)
    • Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
    • Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
    • As a clinical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
    • May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
    • Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides onboarding, training, & mentoring support
    • Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
    • May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

    Key Performance Indicators

    • Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables aligned with IDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders
    • Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases
    • Strong evidence of quality medical review of trial data; support TA through high quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables
    • Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators’ Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders
    • Clearly demonstrates Novartis Values and Behaviors

    Ideal Background

    Education (minimum/desirable):

    Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred

    Languages: Fluent oral and written English

    Experience/Professional requirement:

    • ≥ 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
    • ≥ 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
    • Advanced knowledge of assigned therapeutic area
    • Demonstrated ability to establish strong scientific partnership with key stakeholders
    • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
    • People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
    • Excellent communication skills, written and oral
    • Strong interpersonal skills
    • Excellent negotiation and conflict resolution skills

    Job Type: Contract

    Benefits:

    • 401(k)
    • Dental insurance
    • Employee assistance program
    • Flexible schedule
    • Health insurance
    • Life insurance
    • Paid time off
    • Vision insurance

    Schedule:

    • 8 hour shift

    License/Certification:

    • BCBA (Preferred)

    Shift availability:

    • Day Shift (Preferred)

    Ability to Commute:

    • East Hanover, NJ 07936 (Required)

    Ability to Relocate:

    • East Hanover, NJ 07936: Relocate before starting work (Required)

    Work Location: In person

  • 1 Month Ago

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CRC III
  • DM Clinical Research
  • Jersey, NJ FULL_TIME
  • Clinical Research Coordinator III The Clinical Research Coordinator III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regu...
  • 16 Days Ago

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Clinical Nurse Manager Pediatric Operating Room
  • Clinical Management Consultants
  • Hoboken, NJ FULL_TIME
  • A wonderful opportunity is available for a Nurse Manager of Pediatric Operating Room at a prestigious Children’s hospital in New York, and they are currently conducting interviews! This Level III Trau...
  • 5 Days Ago

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Travel Clinical Research Coordinator
  • Care Access
  • Newark, NJ FULL_TIME
  • What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physici...
  • Just Posted

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Jr. Clinical Research Coordinator
  • SGS
  • Union, NJ FULL_TIME
  • Company DescriptionWe are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 97,000 emplo...
  • 13 Days Ago

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Clinical Research Scientist
  • Global Channel Management, Inc.
  • Madison, NJ FULL_TIME
  • Company DescriptionGlobal Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of e...
  • 13 Days Ago

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0 Clinical Research Manager jobs found in Irvington, NJ area

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Director, Clinical Research Operations
  • NYU Rory Meyers College of Nursing
  • New York, NY
  • Position Summary Provide strategic and operational oversight for the NYU Dentistry Translational Research Center and NYU...
  • 3/27/2024 12:00:00 AM

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Director of Distribution - Full-time, Day
  • Rwjbarnabas Health Corporate Services
  • West Orange, NJ
  • General Summary of Duties: The Site Supply Chain Director (SSCD) is responsible for all supply chain operations within t...
  • 3/26/2024 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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Manager, Clinical Research Budgets/Contracts
  • Hackensack Meridian Health
  • Harrison, NJ
  • 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

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Manager, Clinical Research Budgets/Contracts
  • Hackensack Meridian Health
  • Newark, NJ
  • 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

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Manager, Clinical Research Budgets/Contracts
  • Hackensack Meridian Health
  • Carlstadt, NJ
  • 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

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Manager, Clinical Research Budgets/Contracts
  • Hackensack Meridian Health
  • Hackensack, NJ
  • 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

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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

Irvington is a township in Essex County, New Jersey, United States. As of the 2010 United States Census, the township had a total population of 53,926, having declined by 6,769 (−11.2%) from the 60,695 counted in the 2000 Census, which had in turn declined by 323 (−0.5%) from the 61,018 counted in the 1990 Census.[21] According to the United States Census Bureau, Irvington had a total area of 2.930 square miles (7.589 km2), including 2.928 square miles (7.584 km2) of land and 0.002 square miles (0.005 km2) of water (0.07%). The Elizabeth River (New Jersey)|Elizabeth River]] runs through the ci...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$112,063 to $148,476
Irvington, New Jersey area prices
were up 1.6% from a year ago

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