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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.

What does very clinical mean?

In the context of a Clinical Risk Manager, 'very clinical' typically refers to a focus on clinical practices, patient safety, and healthcare protocols. It indicates a strong emphasis on understanding medical procedures, risk assessment, and compliance with healthcare standards. This term may also relate to the level of clinical knowledge required for effective risk management in healthcare settings.

What do we mean by clinical?

In the context of a Clinical Risk Manager, 'clinical' refers to activities related to patient care, healthcare practices, and medical procedures within healthcare settings. The role involves assessing and managing risks associated with clinical operations, often requiring knowledge of healthcare standards, protocols, and compliance requirements.

What are the key skills and qualifications needed to thrive as a Clinical Risk Manager, and why are they important?

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 is the movie clinical about?

There is no widely known movie titled 'Clinical.' If referring to a film with that name, it typically involves themes related to medical or psychological clinical settings. For a clinical risk manager, understanding such films may help in assessing patient safety and ethical considerations in healthcare environments.

What does a Clinical Risk Manager do?

A Clinical Risk Manager is responsible for identifying, evaluating, and mitigating risks related to patient safety and healthcare operations within a medical facility. They analyze incidents, develop policies to improve patient outcomes, and ensure compliance with healthcare regulations. Clinical Risk Managers also provide training to staff on best practices and collaborate with healthcare teams to implement safety initiatives. Their primary goal is to minimize potential legal liabilities and enhance overall quality of care.

What does it mean for someone to be clinical?

In the context of a Clinical Risk Manager, being clinical refers to applying medical knowledge and clinical practices to identify, assess, and mitigate risks related to patient safety and healthcare quality. It involves understanding clinical procedures, healthcare environments, and regulatory standards to develop effective risk management strategies. Strong communication skills and relevant certifications, such as a nursing or healthcare administration background, are often important in this role.
What job categories do people searching Clinical Risk Manager jobs in Summit, NJ look for? The top searched job categories for Clinical Risk Manager jobs in Summit, NJ are:
What cities near Summit, NJ are hiring for Clinical Risk Manager jobs? Cities near Summit, NJ with the most Clinical Risk Manager job openings:
Clinical Risk Manager jobs near you

Senior Specialist, Clinical Risk Management

Johnson & Johnson

Raritan, NJ • On-site

Full-time

Retirement, PTO

Posted 19 days ago

Johnson & Johnson rating

8.1

Company rating: 8.1 out of 10

Based on 102 frontline employees who took The Breakroom Quiz

32nd of 71 rated pharmaceutical

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson is currently seeking a Senior Specialist, Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Horsham, PA; Spring House, PA; Titusville, NJ or Raritan, NJ.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium - Requisition Number: R-080508

United Kingdom - Requisition Number: R-080509

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

The Senior Specialist, Clinical Risk Management, works with thetrialteamstocoordinatetheidentification, assessment,and mitigation ofquality risks that

couldimpacttrial data integrity, patient safety,well-being,or rights.Throughout the duration of the trial, theSenior Specialist executes data-driven, risk-based trial oversight activities to deliver quality in the execution oftrials (and/or programs),compliance with regulatory requirements and internal procedures, and tomaintaina continued state of inspection readiness.

Key responsibilities:

  • Activelyparticipatesinallstudy activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies

  • Participates inregular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and toidentifypotential new risks oradditionalmitigation needs (trial and/or compound, as assigned)

  • Maintains CQP (Clinical Quality Plans) in quality repository tofacilitateregular progress reviewsof quality support services in addition to risks and mitigations

  • Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations

  • Communicatesandfacilitatesrisk updates to R&D colleagues as part of the regular review cyclethrough Quality Working Groups and Governance Fora, as applicable(trial and/or compound, as assigned).

  • Highlight new potential systemic risk toRDQCRMmanagement

  • Develops and ensures a consistent interpretation of issues that require quality investigations

  • Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.

  • Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities

  • In collaboration with partners inRDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self -Identified, Inspection, Audit)

  • Supportsproactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives,identifyand prepare sites of interest for inspection (including, pre-inspection visit support), ensuresavailability of key documents/recordsand coordinatesmock inspectionincollaboration with RegulatoryCompliance teams.

  • Provides supportfor Investigator, Sponsor-Monitor and third-party inspections includingpost inspection support

  • Providesadvice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals andSubject Matter Experts to ensure consistent interpretation of international regulations and policy.

Qualifications:

  • A minimum of a Bachelor's degree (scientific, medical, or related discipline) is required

  • A minimum of 6 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required

  • Excellent interpersonal, oral,and written communication skills

  • GCP quality and/or clinical trials experience

  • Experience collaborating in a cross-functional team environment

  • Flexibility to respond to changing business needs is required

  • Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required

  • Proficiency in Microsoft Office Applications is required

  • Experience with fundamentals of clinical trial risk management, preferably in a global setting

  • Experience working to ICH guidelines

  • Health Authority Inspection experience (FDA,EMAand other inspectorates)

  • Strong Project Planning/Management skills

  • Experience and/orproficiencywith data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)

  • Proven ability to analyze & interpret collective data to provide insights to drive decision-making

  • Experience in managing escalations and CAPA support/advisement

  • Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)

  • Requires proficiency in speaking and writing English.

  • Up to 10% travel, primarily domestic with some international travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Audit Management, Business Alignment, Business Savvy, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Compliance Management, Data Analysis, Escalation Management, Fact-Based Decision Making, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Tactical Thinking, Vendor Selection

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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