Manager Clinic Risk Management - Quality Management Job at CHRISTUS Health (San Antonio)

Program Manager Clinical Risk Management and Patient Safety - Quality Management

This role also works in conjunction with the System Director of Clinical Risk Ma...

Location

United States , Tyler

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in healthcare-related field required
5 years of healthcare risk management experience required
Proficiency with Microsoft Word, Excel, and PowerPoint required
Certified Professional in Patient Safety (CPPS) or Certified Professional in Healthcare Risk Management (CPHRM) required within 1 year of hire

Job Responsibility

Assists in identifying and evaluating activities or events occurring within the system and facilities, which may affect patient safety, resulting in either patient injury and/ or a potential opportunity to improve care delivery and patient safety
Facilitates implementation and management of a system clinical adverse event investigation process and provides consultation to facility and system staff
Provides leadership for conducting patient safety/ clinical risk assessments and adverse event investigations including root cause analyses and implementation of effective corrective action plans
Demonstrates a high degree of professionalism and communication skills when working with staff involved in adverse events, promoting a culture of no blame and collaboration
Facilitates, tracks, and maintains appropriate records and metrics regarding adverse events and potential for patient and staff safety issues
Uses data and trend analysis experience to facilitate system efforts to analyze data including metrics, surveys, occurrence reports, adverse event investigations, FMEAs, and other information to identify and prioritize clinical risk management/ loss prevention, and patient and staff safety concerns
Supports and contributes to system efforts to carry out FMEAs regarding clinical risk management/ loss prevention, as well as patient and staff safety concerns
Carry out other duties as assigned by leadership
Strive to increase and share current knowledge in the areas of clinical risk management and patient and staff safety
Possesses excellent organizational and analytical skills

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Theatre Quality Lead

The Theatre Quality Lead (CNM2) promotes, facilitates and supports the provision...

Location

Ireland , Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Be registered in the general division of the Register of Nurses maintained by NMBI
Have at least five years recent relevant post-registration nursing experience (full-time or equivalent hours part-time) in an acute hospital setting and a minimum of two years nursing experience in Theatre nursing
Have a recognised post-registration nursing course - Higher Diploma or Post Graduate appropriate to the position is essential i.e. Quality, or in pursuit of same
Proven clinical and professional management, risk management and clinical audit ability
Quality focus
Excellent interpersonal and communication skills
Management skills
Leadership skills
Negotiating Skills
Risk Management

Job Responsibility

Ensure compliance with all relevant Blackrock Health Hermitage Clinic guidelines, policies, procedures and relevant legislation and regulatory requirements
Encourage continuous review and evaluation of policies, guidelines and existing practices through regular audit programmes and review
Promote a culture of continuous quality improvement across the Operating Theatre Department
Set and monitor core objectives, standards and key performance indicators for the service
Lead out on the requirements of the hospital’s accreditation process
Ensure the department’s readiness for HIQA inspections
Participate fully in the requirement of the hospital’s risk management programme
Promote the delivery of a high standard of care to all patients
Work with members of the multidisciplinary team in devising Standard Operating Procedures
Provide clinical nursing leadership in proactively addressing ethical and quality of services issues

Fulltime

Risk Manager & Design Control Engineer

Come and join BONESUPPORT as Risk Manager & Design Control Engineer. This is an ...

Location

Sweden , Lund

Salary:

Not provided

Cerament (Bonesupport)

Expiration Date

Until further notice

Requirements

Technical academic background at Bachelor level or higher
At least four years’ relevant experience from the medical device industry
In‑depth knowledge of ISO 14971 and medical device regulations (e.g., EU MDR, FDA Quality System Regulation and ISO 13485)
Hands‑on experience with Design Controls as per FDA and ISO 13485
Strong technical writing and documentation skills
Ability to interpret and implement regulatory changes into existing systems
Collaborative mindset with excellent communication and project management skills
Fluency in English

Job Responsibility

Plan, lead and implement Risk Management activities according to ISO 14971 across Product Lifecycle Management (PLM) and New Product Development (NPD)
Support Design Controls activities, including labelling
Ensure that products remain in compliance with applicable regulatory requirements and updated standards, guidelines and regulations throughout the lifecycle by updating, reviewing and establishing engineering documents and Standard Operating Procedures (SOPs)
Hold main responsibility for the risk management process in accordance with ISO 14971
Collaborate closely with Quality, Regulatory, Research, Clinical and Operations, as well as external partners

New

Executive Director, Quality Data Analytics and Process Management

In this vital role as the Executive Director, R&D Quality Data Analytics & Proce...

Location

United States , Thousand Oaks

Salary:

241843.70 - 327200.30 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Master's degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Bachelor's degree and 12 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Develop and execute a multi-year strategy for process management, data analytics, document management, and risk management aligned to R&D Quality priorities
Serve as a strategic advisor to the Head of R&D Quality on process performance, clinical quality trends, operational risk, and digital opportunities
Build a high-performing organization focused on innovation, simplification, and measurable business impact
Act as business process owner for core R&D Quality processes such as deviations/nonconformances, CAPA, change control, training (metrics) and risk management
Support the R&D business process owners to develop global standards, process controls, KPIs, roles/responsibilities, and governance for assigned processes
Ensure simplification, standardization, and modernization of document structures and approval workflows in partnership with Global Quality
Ensure processes are compliant with applicable GxP regulations and integrated across functional boundaries
Lead periodic process reviews, health checks, and continuous improvement initiatives related to these processes
Establish a modern analytics strategy for R&D Quality using dashboards, predictive indicators, trend analysis, and self-service reporting tools
Develop executive dashboards for quality performance, compliance health, process efficiency, inspection readiness, and risk visibility

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models where possible

Fulltime

Director of Clinical Risk Management

The Director of Clinical Risk Management provides leadership and oversight of al...

Location

United States , Norfolk

Salary:

Not provided

Old Dominion University

Expiration Date

Until further notice

Requirements

Expert-level understanding of clinical care processes, standards of care, patient safety science (human factors, high-reliability principles, just culture), diagnostic error, communication failures, transitions of care, medication safety, informed consent, documentation standards, and event prevention
Ability to provide authoritative, real-time clinical risk guidance to physicians, APPs, nursing, and leadership during active events—balancing patient safety, ethical obligations, and liability exposure across diverse ambulatory and procedural settings
Demonstrated knowledge of specialty-driven risk patterns and controls for OB/GYN, Surgery & Procedural Practices, Radiation Oncology, Psychiatry & Behavioral Sciences, Family & Community Medicine / PM&R
Advanced working knowledge of federal and state healthcare requirements and risk implications
Ability to partner with counsel to interpret requirements, set defensible clinical risk positions, and embed compliance into operational workflows
Strong knowledge of professional liability/medical malpractice concepts
Ability to oversee investigations with a “claims-ready” approach while prioritizing patient safety improvements
Deep familiarity with ambulatory and academic medical group operations, quality structures, credentialing/privileging concepts, interdepartmental workflows, emergency response pathways, patient grievances, and risk controls across clinical sites
High proficiency with RMIS platforms and comfort leveraging EMR data
Advanced understanding of healthcare contracting risk

Job Responsibility

Provides leadership and oversight of all clinical and operational risk management functions for the Elmer and Joan Brock Virginia Health Sciences at ODU (VHS), the EVMS Medical Group, and affiliated healthcare entities
Assists in implementing and managing a comprehensive enterprise risk management (ERM) framework that integrates clinical, operational, financial, and reputational risk strategies across academic and clinical environments
Ensures healthcare-related risks are proactively identified, assessed, and mitigated
Maintains compliance with accreditation and regulatory standards
Promotes a culture of patient safety and institutional accountability

Fulltime

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Manager Clinic Risk Management - Quality Management

Job Description

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