Clinical Risk and Quality Manager Job at 360 Resourcing Solutions (Galway or Dublin)

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

Quality Safety & Risk Officer

The role of the QSR Officer works within the Mission and Mission in Action of Ha...

Location

Australia , Greenwich; Prairiewood

Salary:

Not provided

HammondCare

Expiration Date

Until further notice

Requirements

Commitment to engage and align with HammondCare’s Christian Mission, Motivation and Mission in Action
Bachelor's degree in Nursing, Allied Health, Health Science, or a related field (essential)
Strong knowledge of healthcare quality, safety, and risk management frameworks
Ability to interpret and apply regulatory requirements and accreditation standards
Analytical and problem-solving skills for incident investigation and risk assessment
Excellent communication and stakeholder engagement skills
Strong project management and organizational skills
Ability to lead training and education programs
A current driver’s license and safe driving record. Willingness to travel between HammondCare’s sites, from time to time
Strong administrative and computer skills including database management and Microsoft Office applications (particularly Microsoft Word, Excel, and Outlook)

Job Responsibility

Assist the Head of QSR/QSR Manager in investigations, reviews and audits as scheduled or triggered by changes in service delivery or requested by the Head of QSR
Escalate concerns or sentinel events to the Head of QSR
Support services in meeting the requirements of regulatory visits and other external visits and provide support during these audits
Quality improvement and auditing
Risk Management and Mitigation
Support services in understanding the effectiveness of the operations of their services, alignment with the Mission and Mission in Action and the ongoing trends
Monitor and investigate incidents, adverse events, and near misses
Conduct root cause analyses and recommend corrective actions
Support staff in incident reporting and learning from safety events
Promote a culture of patient-centred care and continuous improvement

What we offer

NFP salary packaging ($15,900 tax free) plus meals and entertainment benefit (up to $2,650 tax free)
Additional leave purchase options and 14 weeks paid parental leave
Flexible working options, including hybrid arrangements
Discounts on everyday products and services
Discounted healthcare memberships - access to network of fitness centres and pools for employees and families
Free access to independent counselling support for employees and families
Health & Wellbeing programmes
Reward & Recognition programmes
Referral bonuses
Career and professional development opportunities

Parttime

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

Senior Clinical Trial Manager

The Senior Clinical Trial Manager (Sr. CTM) will manage the planning, execution,...

Location

United States , Waltham

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of clinical trial experience, including direct management of CROs and vendors
Proven ability to lead cross-functional study teams and drive clinical programs forward independently
Deep understanding of GCP, ICH guidelines, and regulatory frameworks relevant to global clinical trial management
Strong problem-solving, organizational, and analytical skills with the ability to anticipate challenges and implement solutions
Excellent written and verbal communication skills, including stakeholder presentations and vendor negotiations
Ability to manage multiple priorities in a fast-paced environment and lead initiatives with minimal oversight
Proficient in Microsoft Office Suite, and working knowledge of project management tools (e.g., MS Project, Smartsheet)
Must be able to travel as needed
Bachelor’s degree in life sciences or a related field

Job Responsibility

Serve as the primary operational lead for assigned clinical trials
accountable for end-to-end trial execution, including oversight of CROs and vendors, from study start-up through close-out
Lead cross-functional trial teams to ensure alignment on timelines, deliverables, risk mitigation, and study objectives
Independently manage key trial activities, such as protocol development, site selection, study conduct, monitoring, data review, and database lock
Oversee and review key clinical trial documents (e.g., informed consent forms, investigator brochures, monitoring plans), ensuring quality and regulatory compliance
Monitor CRO performance to ensure adherence to study plans, timelines, budgets, and quality expectations
escalate and resolve issues proactively
Lead development and review of study plans and vendor SOPs
ensure appropriate documentation and risk mitigation strategies are in place
Ensure timely data query resolution, review of protocol deviations, and follow-through on site-related corrective actions

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Employee in quality management and/or regulatory affairs

As a professional QM/RA associate, you will be responsible for tasks in Quality ...

Location

Austria , Salzburg

Salary:

Not provided

Brainlab

Expiration Date

Until further notice

Requirements

Experience or training in Quality Management, preferably in the medical device sector (ISO 13485) or any industry with high regulatory standards
Knowledge of EU MDR (Medical Device Regulation) and experience with Class II or higher medical devices is an advantage
Familiarity with clinical evaluations and post-market surveillance processes under MDR guidelines is highly desirable
Knowledge of international regulations and certifications for medical devices is a plus
Fluent in German and English (written and spoken)
Flexible, team-oriented, and eager to work in an international environment

Job Responsibility

Support and collaborate across all areas of Quality Management (QM)
Ongoing control, improvement, and optimization of quality management processes and standards
Assist in creating and reviewing deviation reports, risk management plans, and CAPA (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions
Ensure the implementation and monitoring of regulatory requirements for medical devices
Assist with international product certifications and approvals
Liaise with regulatory bodies and authorities, including correspondence with notified bodies (globally)
Support clinical evaluations, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards
Participate in post-market surveillance activities, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness
Support internal and external audits as well as supplier audits
Assist R&D with documentation and support the development process

What we offer

A motivating work atmosphere in a young, dynamic team
An exciting and varied scope of assignments customized for your skills and interests
The opportunity to grow with us, be directly involved and participate in our company’s success
A secure, permanent full-time contract
Generous social benefits within our culturally diverse enterprise
Freshly-cooked meals and healthy snacks provided daily
Good public transport connections and parking facilities available
Flexible working hours
Support for daily obligations (childcare, etc.)

Fulltime

Associate Director, Clinical Data Management

The Associate Director, Clinical Data Management plays a key role within the Cli...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors
Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes
Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management
Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting
Proven success in managing vendor relationships and functional service provider (FSP) partnerships
Strong track record of building effective relationships and managing expectations with external partners and vendors
Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation
Bachelor’s degree or higher in Life Science or related discipline

Job Responsibility

Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress
Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors
Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)
Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards
Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment
Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency
Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences
Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)
Monitor vendor performance and quality
escalate issues to management and implement corrective actions as appropriate

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Clinical Risk and Quality Manager

360 Resourcing Solutions

Location:
Ireland , Galway or Dublin

Category:
Nursing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 15, 2026

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Program Manager Clinical Risk Management and Patient Safety - Quality Management