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Clinical Research Leader

Remote in New Brunswick, NJ, US • Posted 5 hours ago • Updated 5 hours ago

Contract W2

On-site

Fitment

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Job Details

Skills

Research and Development
Standard Operating Procedure
Accountability
Payments
Statistics
Publications
EDS
Data Collection
Collaboration
Partnership
Team Leadership
Business Plans
Messaging
Policies and Procedures
Supervision
Decision-making
Life Sciences
Nursing
Biology
RAC
Google Cloud
Google Cloud Platform
ISO 9000
Medical Devices
Science
Dynamics
Health Care
Clinical Trials
Clinical Research
Product Development
Management
LCM
Research
Budget
Regulatory Compliance
Presentations
Technical Writing

Summary

Clinical Research Leader
Summary:
This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Responsibilities:

Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-Google Cloud Platform, applicable legislation and Company Standard Operating Procedures
May serve as the primary contact for clinical trial sites (e.g. site management)
Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision
Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on
Management/oversight of ordering, tracking, and accountability of investigational products and trial materials
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Oversee the development and execution of Investigator agreements and trial payments
Responsible for clinical data review to prepare data for statistical analyses and publications
If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
Track and manage assigned project budgets to ensure adherence to business plans
Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
Develop a strong understanding of the pipeline, product portfolio and business needs
May serve as the clinical representative on a New Product Development team
May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports
May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
Perform other duties assigned as needed
Generally manages work with limited supervision, dependent on project complexity Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations

Education:
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
Experience:

Previous experience in clinical research or equivalent is required
Experience working well with cross-functional teams is required
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, Google Cloud Platform, ISO 14155, MDR, MEDDEV)
Clinical/medical background a plus
Experience managing projects a plus
Medical device experience highly preferred

Functional and Technical Competencies:

Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects
Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations
Strong presentation and technical writing skills

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 876135
Posted 5 hours ago

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