Find clinical data lead Jobs in dublin, d

Risk Surveillance Lead
Novartis —Dublin, County Dublin
- Full-time
- English
- Bachelor's degree
- No degree
Head of Data Governance, Anonymization and Quality
Novartis —Dublin, County Dublin
- Full-time
- Doctoral degree
- Computer Science
- Research
14d
Senior Real World Data Scientist
AstraZeneca —Dublin, County Dublin
- Master's degree
- SQL
- EMR systems
8d
Senior Real World Data Scientist
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Master's degree
- SQL
- EMR systems
8d
Technical Product Manager
Optum —Dublin, County Dublin
- Full-time
- Computer Science
- Bachelor's degree
- Agile
Head of Clinical Affairs
Deciphex —Dublin, County Dublin
- Full-time
- Hybrid work
- Research
- Annual leave
Quick apply
QA Manager & Qualified Person (QP)
RxSource —Dublin, County Dublin
- Engineering
- Bachelor's degree
- No degree
Higher Specialist Training (HST) Programme Coordinator
RCPI —DUBLIN 2, County Dublin
- €35,000 a year
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Work from home
Quick apply
10d
Health and Social Care Transformation Senior Manager, Hybrid
Deloitte —Dublin, County Dublin
- Full-time
- Hybrid work
- Business
Business Optimisation Lead
Charles River Laboratories —Dublin, County Dublin
- Full-time
- Data analysis skills
- Analysis skills
- Project management
- Annual leave
9d
Health & Social Care Transformation Director, Hybrid
Deloitte —Dublin, County Dublin
- Full-time
- Hybrid work
- Business
Programme Lead
Teckro Limited —Dublin, County Dublin
- Full-time
- Hybrid work
- Hotel
- Project management
- No degree
- Gym membership
- Life insurance
Quick apply
Internal Account Director (Recruitment & Retention)
サイネオス・ヘルス —Dublin, County Dublin
- €97,300–€170,300 a year
- Remote
- Microsoft Office
- Leadership
Vice President, PI Capability Strategy
Optum —Dublin, County Dublin
- Full-time
- Engineering
- Bachelor's degree
- No degree
Technical Consultant
Medtronic —Dublin, County Dublin
- €52,800–€79,200 a year
- Full-time
- Nursing
- Driving
- Operating room
2d
Clinical Specialist Physiotherapist: Lymphoedema and Breast Care
Blackrock Health Blackrock Clinic —Dublin, County Dublin
- Part-time
- Clinic
- Leadership
- Communication skills
- Employee assistance program
Quick apply
11d
Associate Director, Pharma Account Manager
Optum —Dublin, County Dublin
- Full-time
- Management
- Master's degree
- No degree
Quality Assurance Specialist - Hybrid
TCP Homecare —Clondalkin, County Dublin
- Full-time
- Hybrid work
- Communication skills
- Annual leave
- Employee discount
Quick apply
7d
Sr. Manager, Medical Writing
Alfasigma Group —Dublin, County Dublin
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Clinical Engagement Project Manager
Teckro Limited —Dublin, County Dublin
- Full-time
- Hybrid work
- Hotel
- Project management
- Presentation skills
- Gym membership
- Life insurance
Quick apply

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Risk Surveillance Lead

Novartis -
Dublin, County Dublin

Apply Now

Job details

Full-time

Qualifications

English
Quality management
Google Cloud Platform
Bachelor's degree
Surveillance

Full job description

Summary

The Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall account-ability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles.

This role can be based in our offices in London, UK, Dublin, Ireland or Barcelona, Madrid, Spain. Please apply to the relevant job advertisement for your location.

Please note that Novartis cannot sponsor visas for these locations. Relocation is not available for these locations.

#LI-Hybrid
On site expectation of 12 days per month/ave. 3 days per week in the office.

About the Role

Major Accountabilities:

Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined
Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)
Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
Conduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issues
Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies
Supports and participates in internal and external audits and inspection
Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
Identifies and shares lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit

Experience:

Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience

Minimum of 4 years of experience in the pharmaceutical or CRO industry
Preferred minimum of 1 years of experience in Risk Based Quality Management
Robust understanding of the drug development process and clinical trial execution
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
Knowledge of RBQM IT systems or other data analytic systems
Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
Demonstrated ability to effectively lead cross functional team meetings
Experience forming cross-functional collaborations; strong interpersonal skills
Supports a culture of continual improvement and innovation; promotes knowledge sharing
Ability to influence without authority
Thinks creatively; challenges the status quo

Languages:

English: fluent written and spoken

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Development

Business Unit

Development

Location

Ireland

Site

Dublin (NOCC)

Company / Legal Entity

IE02 (FCRS = IE002) Novartis Ireland Ltd

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

Apply Now

Refine Your Search

clinical data lead jobs in dublin, d

Risk Surveillance Lead

Head of Data Governance, Anonymization and Quality

Senior Real World Data Scientist

Senior Real World Data Scientist

Technical Product Manager

Head of Clinical Affairs

QA Manager & Qualified Person (QP)

Higher Specialist Training (HST) Programme Coordinator

Health and Social Care Transformation Senior Manager, Hybrid

Business Optimisation Lead

Health & Social Care Transformation Director, Hybrid

Programme Lead

Internal Account Director (Recruitment & Retention)

Vice President, PI Capability Strategy

Technical Consultant

Clinical Specialist Physiotherapist: Lymphoedema and Breast Care

Associate Director, Pharma Account Manager

Quality Assurance Specialist - Hybrid

Sr. Manager, Medical Writing

Clinical Engagement Project Manager

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