Sr Principal Clinical Data Scientist

Found in: beBee jobs IE - 1 week ago

Dublin, Dublin City, Ireland Novartis Farmacéutica Full time
Sr Principal Clinical Data Scientist (Project Data Manager)

Job ID 369943BR

Jan 30, 2024

Ireland

About the Role

Senior Principle Clinical Data Scientist
100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as [Role] #GCO
The Senior Principal Clinical Data Scientist is responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s). Coaches, provides leadership and enhances capability across CDAM ensuring consistency across assigned program(s) . Provide pro-active and effective communication to DMLT, Global Program teams and other stakeholder groups. Ensure consistently high quality data (in alignment with the Novartis Clinical Data Quality Statement) available for analysis and reporting.
Your responsibilities include, but are not limited to:

• Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits.

• Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e, ensuring consistency across data quality plans

• Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director. Proficient in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards

• Maintains awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs. Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation, program standards and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints

• Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions. Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program.

• Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution. Develops risk management strategies to prevent data quality issues from derailing projects

• Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives. Ensures adherence to ICH GCP, DM standards, SOPs/WPS and process guidelines. Responsible for quality control and audit readiness of all assigned data management deliverables and Programs

• Provide adequate quality oversight to important tasks and activities. Ensures all errors at any stage are assessed for systematic impact.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

What you'll bring to the role:
Required Experience & Qualifications:

• Ideally 8 years' experience in Drug Development with at least 5+ years' in Clinical Data Management

• Excellent verbal and written skills University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).

• Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines

• Excellent understanding of clinical trials methodology, GCP and medical terminology

• Proven ability to interrogate and view data through various programming/GUI techniques.

• Must be able to anticipate challenges and risks and proactively suggest/implement solutions

• Ability to work under pressure demonstrating agility through effective and innovative team leadership. Ability to influence and communicate across functions and to external stakeholders

• Understanding of project management concepts in order to aid delivery across a program
Desirable Experience & Qualifications:

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.

• Excellent interpersonal skills and proven ability to operate effectively in a global environment.

#J-18808-Ljbffr

  • Senior Clinical Data Scientist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Senior Clinical Data Scientist (Trial Data Manager) Job ID 369937BR Jan 30, 2024 Ireland About the Role 100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely...

  • Principal/Senior Principal Microbiologist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland eli lilly and company Full time

    Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences page is loaded Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences Apply locations Ireland, Limerick time type Full time posted on Posted 2 Days Ago job requisition id R-61705 At Lilly, we unite caring with discovery to make life better...

  • Senior/Principal/Senior Principal Microbiologist

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland eli lilly and company Full time

    Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences page is loaded Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences Apply locations Ireland, Limerick time type Full time posted on Posted 2 Days Ago job requisition id R-61705 At Lilly, we unite caring with discovery to...

  • Purification Process Development Scientist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer Global are currently recruiting for aProcess Development ScientistJob Title: Purification Process Development Scientist (Level 2)Department: Manufacturing Science and Technology - Process DevelopmentPosition Reports to: Principal Scientist (Level 4 / Manager), Process DevelopmentWhy Patients Need YouPfizer's purpose...

  • Lead Data Scientist

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland Ireland: Mastercard Ireland Limited Full time

    Our Purpose We work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our...

  • Lead Data Scientist

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland Mastercard Full time

    Our PurposeWe work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our...

  • Medical Scientist, Staff Grade

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland oasis group Full time

    Medical Scientist, Staff Grade - Microbiology Limerick, Ireland Full time, Permanent Who We Are UL Hospitals Group is made up of 6 hospital sites in the Midwest. The 6 sites function as a single hospital system. The 6 hospitals are:University Hospital LimerickUniversity Maternity Hospital LimerickNenagh HospitalEnnis HospitalCroom Orthopaedic HospitalSt....

  • Sr. Software Engineer

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland CrowdStrike Holdings, Inc. Full time

    Sr. Software Engineer - Backend (CharlotteAI) (Remote) page is loaded Sr. Software Engineer - Backend (CharlotteAI) (Remote) Apply locations Ireland - Remote Italy - Remote France - Remote Spain - Remote Netherlands - Remote time type Full time posted on Posted Yesterday job requisition id R16528 #WeAreCrowdStrike and our mission is to stop breaches. As a...

  • Sr. Associate

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland eli lilly and company Full time

    Sr. Associate - Quality (Facilities, Maintenance, Utilities) page is loaded Sr. Associate - Quality (Facilities, Maintenance, Utilities) Apply locations Ireland, Limerick time type Full time posted on Posted 4 Days Ago job requisition id R-61263 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global...

  • 2/2 Principal Statistical Programmer

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine –...

  • Analytical Scientist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Analytical Scientist Cpl in partnership with our client Pfizer are currently recruiting for Analytical Scientists based in their Grange Castle Site. This is an exciting opportunity to join the Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant which is situated on a 90-acre site in South Dublin. Grange Castle's state-of-the-art technology &...

  • Principal Associate

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland eli lilly and company Full time

    Principal Associate - Computer Systems Quality Assurance page is loaded Principal Associate - Computer Systems Quality Assurance Apply locations Ireland, Limerick time type Full time posted on Posted 4 Days Ago job requisition id R-61388 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare...

  • Sr. Engineer

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland Amgen Full time

    Senior Engineer – System OwnerAmgen Dun Laoghaire - DublinOverview:This position will be part of the filling group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Senior Engineering Manager, Maintenance. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous...

  • Sr. Engineer Drug Process Development

    Found in: beBee jobs IE - 3 days ago

    Dublin, Dublin City, Ireland Amgen Full time

    Job Posting Title Sr Engineer - Drug Process DevelopmentCareer Category Process DevelopmentEmployee Subgroup TBCCountry (State/Region) IrelandLocation (City) Ireland - ADLAmgen Job DescriptionThe Sr Engineer provides process development technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global...

  • Analytical Scientist

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are currently recruiting for Analytical Scientists based in their Grange Castle Site. This is an exciting opportunity to join the Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant which is situated on a 90-acre site in South Dublin. Grange Castle's state-of-the-art technology & production expertise...

  • Senior Clinical Trial Specialist

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full time

    We are currently partnering with a Galway based medical device start-up who are looking to hire a Senior Clinical Trial Specialist as they expand. Job Summary: The Senior Clinical Trial Specialist you will be responsible for planning, executing, and overseeing clinical trials to ensure they are conducted in accordance with regulatory requirements,...

  • Process Scientist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are currently recruiting for aProcess Scientist - Small Scale FlexBackground:This is an ideal development opportunity to join a dynamic team who provide process science support/ new product tech transfer into the drug substance facility at Pfizer Grange Castle. The jobholder works with the Technical Services teams...

  • Sr Associate QC

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Amgen Full time

    Job Summary: QC CAS - Sr AssociateUnder minimal supervision, responsible for one or more of the following activities in QC including analytical testing of EU Release, Commercial, Stability, Utilities, raw materials and Validation. Contributes to team by ensuring the quality of the tasks/services provided by self Contributes to the completion of Milestones...

  • Sr. Manager, Site Reg Affairs

    Found in: beBee jobs IE - 2 weeks ago

    Dublin, Dublin City, Ireland Amgen Full time

    Group PurposeTo facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.Job SummaryThe RA CMC Sr. Mgr. supports ADL Site and is responsible for providing guidance and leadership to the ADL...

  • Process Scientist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Pfizer Full time

    Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure...