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Clinical Risk Manager Jobs in Flemington, NJ (NOW HIRING)

Jj

Manager, Clinical Data Management

Titusville, NJ · On-site +1

Clinical Data Management Job Category: Professional All Job Posting Locations: Horsham ... Advanced project and risk management skills with an established track record delivering successful ...

Jj

Manager, Clinical Data Management

Raritan, NJ · On-site +1

Clinical Data Management Job Category: Professional All Job Posting Locations: Horsham ... Advanced project and risk management skills with an established track record delivering successful ...

Jj

Manager, Clinical Data Management

Horsham, PA · On-site +1

Clinical Data Management Job Category: Professional All Job Posting Locations: Horsham ... Advanced project and risk management skills with an established track record delivering successful ...

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Clinical Risk Manager information

How does a clinical risk manager collaborate with clinical staff to improve patient safety?

Clinical Risk Managers work closely with nurses, physicians, and other healthcare professionals to identify potential risks and prevent adverse events. They often conduct root cause analyses after incidents, facilitate safety training sessions, and lead multidisciplinary meetings to discuss risk mitigation strategies. By fostering open communication and encouraging reporting of near-misses, they help create a culture of safety and continuous improvement within the healthcare facility.

How to become a clinical risk manager?

To become a clinical risk manager, individuals typically need a bachelor's degree in nursing, healthcare administration, or a related field, followed by relevant work experience in healthcare settings. Many pursue certifications such as the Certified Professional in Healthcare Risk Management (CPHRM) to enhance their credentials. Strong knowledge of healthcare regulations, risk assessment skills, and the ability to analyze clinical data are essential for success in this role.

What do clinical risk managers do?

Clinical risk managers are responsible for identifying, assessing, and reducing risks related to patient safety and healthcare quality within medical facilities. They analyze incident reports, develop safety protocols, and ensure compliance with healthcare regulations, often using data analysis tools and requiring relevant certifications. Their goal is to minimize adverse events and improve overall clinical outcomes.

What are the key skills and qualifications needed to thrive as a clinical risk manager?

To thrive as a Clinical Risk Manager, you need a solid background in healthcare, risk management, and regulatory compliance, typically supported by a clinical degree and certifications such as CPHRM (Certified Professional in Healthcare Risk Management). Familiarity with incident reporting systems, electronic health records, and risk analysis tools is essential. Strong analytical thinking, communication, and problem-solving skills enable effective collaboration with healthcare teams and leadership. These competencies are vital for identifying, mitigating, and preventing risks to ensure patient safety and regulatory compliance in healthcare organizations.

What is the difference between Clinical Risk Manager vs Clinical Risk Coordinator?

AspectClinical Risk ManagerClinical Risk Coordinator
CertificationsCPHRM, RACCPHRM, RAC (sometimes)
Work EnvironmentHospitals, healthcare organizations, risk management departmentsClinics, healthcare facilities, risk management teams
ResponsibilitiesOversees risk management programs, develops policies, analyzes risksAssists in risk assessments, supports risk mitigation efforts, data collection

The Clinical Risk Manager typically holds more advanced certifications and has broader responsibilities in developing and overseeing risk management strategies. The Clinical Risk Coordinator supports these efforts through data collection and risk assessment assistance. Both roles are essential in healthcare risk management but differ in scope and seniority.

What cities near Flemington, NJ are hiring for Clinical Risk Manager jobs?

Cities near Flemington, NJ with the most Clinical Risk Manager job openings:

Clinical Risk Manager jobs near you

Clinical Operations Manager

Zydus Therapeutics Inc.

Pennington, NJ • On-site, Remote

Full-time

Re-posted 7 hours ago

Job description

Description

Responsibilities:

  • Lead operational execution of assigned clinical trials under both:
    • In-house managed models (direct CRA/site       oversight), and
    • Outsourced models (full-service or functional CRO partnerships)
  • Ensure consistent application of sponsor SOPs regardless of delivery model
  • Drive study start-up, enrollment, and close-out milestones across all regions
  • Directly manage CRAs and/or Lead CRAs assigned to in-house managed studies
  • Provide functional oversight of IHCRAs - Assign, prioritize, and track IHCRA work activities,  including:

o Site document review and tracking

o Remote monitoring support and follow-up

o Query and action item tracking

o TMF/eTMF filing support and completeness checks

  • Review IHCRA outputs for quality, timeliness, and compliance
  • Provide feedback, coaching, and training input to IHCRAs in collaboration with line managers
  • Assign sites, review  monitoring plans, and ensure adequate site coverage
  • Review monitoring visit reports, follow-up letters, and issue resolution
  • Coach and mentor CRAs to ensure monitoring quality and compliance
  • Provide sponsor oversight of CROs, vendors, and functional service providers
  • Review and approve CRO deliverables (monitoring plans, reports, metrics, TMF status)
  • Ensure CRO performance aligns with contracted scope, KPIs, timelines, and quality standards
  • Lead governance  meetings, performance reviews, and escalation management
  • Ensure clear documentation of sponsor oversight activities per ICH E6(R2/R3)
  • Experience supporting and overseeing both Risk-Based Monitoring (RBM) strategies and traditional      100% SDV monitoring models, as appropriate to study design, risk profile, and regulatory expectations
  • Ability to transition studies between RBM and 100% SDV approaches based on protocol requirements, inspection feedback, or sponsor risk assessments
  • Oversight of monitoring plans to ensure:

o Appropriate SDV/SDR levels

o Centralized monitoring outputs are reviewed and actioned

o On-site, remote, and hybrid monitoring approaches are appropriately applied

  • Oversee protocol  deviations, CAPAs, and quality issues
  • Identify operational risks early and implement mitigation strategies
  • Act as escalation  point for complex site, CRA, or CRO issues
  • Partner with sites to support enrollment, retention, and protocol adherence
  • Ensure studies are inspection-ready at all times
  • Support and participate in regulatory inspections and audits (FDA, EMA, Health      Authorities)
  • Ensure timely TMF completeness and eTMF oversight (in-house and CRO-maintained TMFs)
  • Collaborate with Clinical Development, Data Management, Biostatistics, Safety, Regulatory,      and Supply Chain
  • Provide operational input into protocols, ICFs, feasibility, and country/site strategy
  • Support investigator meetings, site trainings, and study communications
  • Provide regular study status updates to senior management
  • Maintain oversight trackers, risk logs, issue logs, and KPI dashboards
  • Ensure accurate documentation of decisions, deviations, and actions
  • Any other duties as assigned by Supervisor.

Requirements

Qualifications

Education

  • Bachelor's degree in      Life Sciences, Nursing, Pharmacy, or related field (required)
  • Advanced degree      preferred

Experience

8+ years of clinical research experience, including management of both in-house and outsourced trials, with 6+ years of onsite monitoring CRA experience, including people management and CRO oversight exposure

  • Experience managing      global or multi-regional Phase I-III trials preferred

Core Competencies & Skills

  • Strong understanding  of sponsor oversight responsibilities under ICH-GCP
  • Hands-on experience  with both direct CRA management and CRO governance
  • Expertise in RBM, centralized monitoring, and quality risk management
  • Strong leadership, communication, and stakeholder management skills
  • Ability to manage      multiple studies and vendors simultaneously
  • Proficiency with CTMS, eTMF, and clinical systems

Preferred Experience

  • Sponsor-side experience in biotech or pharmaceutical companies
  • Experience  transitioning studies between in-house and outsourced models
  • Experience in complex or rare disease trials 
  • Prior inspection  support experience 

Travel

Up to 60% travel- Focused on co-monitoring, audit readiness visits, CRO oversight visits, inspections

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