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Novartis
Carlsbad, CA, United States
14 hours ago
Novartis
East Hanover, NJ, United States
14 hours ago
Novartis
Carlsbad, California, United States
14 hours ago

Description

1 in 5 men and 1 in 6 women worldwide develop cancer during their lifetime, and far too many will lose their battle every year! At Navigate we envision a disease-free world - our talented and passionate team is at the forefront of enabling drug development by using transformative science to deliver high quality, world class clinical biomarker solutions so we can one day realize that vision.

Join us on our journey to turning innovative treatment ideas into reality to improve and extend patient lives across the globe. Navigate Biopharma, a fully owned subsidiary of Novartis, provides assay development, clinical trial testing, and companion diagnostics services to companies in the precision medicine field. At present, Navigate supports 100+ clinical trials from 30+ pharma, biotech, and diagnostic companies, including 8 of the top 15 oncology companies globally.

The Clinical Data Analyst ensures the successful end-to-end operation of clinical data transfer process. The role supports the efficient planning and execution of all activities associated with data transfers. This role serves as the data management specialist on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables

ESSENTIAL DUTIES AND RESPONSIBILITIES
- Work in a GMP/GCP/GLP/CLIA regulated environment and follow all applicable regulations
- Work with the project management, Laboratory staff and GxP Systems team on study start up activities, including data entry, database screen testing, edit/check software tool development and perform testing
- Work in conjunction with study project managers and technical laboratory staff to understand data transfer specifications and study timelines to help assess and ensure that proposed solutions satisfies requirements, timelines, broader data management and BioPharma goals.
- Work with CDM, GxP systems and Project Management teams to facilitate agreements, maintain project timelines, drive project completion, raise issues as appropriate and maintain study data transfer deadlines.
- Communicates with Project Managers, MIRTH team, LIMS team and test method leads on a regular basis to meet data management deliverables on the multiple projects and ensures milestones meet timeline and quality deliverables
- Communicate data issues and/or query trends to Sponsor and/or project team, as appropriate
- Assess issues / generate solutions in data handling built by the changing requirements in clinical data processing.
- Raise any potential or actual issues to supervisor, project team, and/or Sponsor in a timely manner, and follow issues through to resolution
- Assists in User Acceptance testing
- Review clinical data as per SOP, protocol, and study specific guidelines
- Handles confidential material and adhere to data security and confidentiality requirements
- Provides status updates related to project tasks to management
- Other Duties as assigned

OTHER RESPONSIBILITIES:

- Ensuring that Quality Events such as incidents and deviations are accurately detailed, and for supporting/owning the immediate remediation and preventative actions
- Ensuring change requests are accurately initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
- Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
- Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

- Demonstrated experience and understanding of techniques directly applicable to Clinical Trial related research (molecular and cellular biological techniques such as PCR, flow cytometry, IHC, etc.) is strongly preferred.
- MS with a minimum of 2 years direct proven experience in Clinical Trials (Immunology or Oncology preferred) OR BS with a minimum of 4 years of direct proven experience in data management (Clinical Trials preferred).
- Strong background in handling various types of laboratory generated data across various molecular and protein-based platforms
- Excellent verbal and written communications skills and ability to interact with personnel at all levels cross-functionally
- Ability to think critically and use good problem-solving skills
- Experience with Flow cytometry, immuno histo chemistry, IHC
- Knowledge of GxP and validation experience
- Data application configuration experience
- Clinical research and clinical trial experience preferred

PHYSICAL DEMANDS:
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

WORK ENVIRONMENT:
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.

The work environment involves moderate exposure to unusual elements including: extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company's Safety and Injury, Illness and Prevention Plans.

Why consider Novartis?

799 million. That's how many lives our products touched in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

Imagine what you could do at Novartis!

COMMITMENT TO DIVERSITY & INCLUSION:

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

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Information

  • Job ID: 59395063
  • Location:
    Carlsbad, California, United States
  • Position Title: Clinical Data Analyst
  • Company Name: Novartis
  • Job Function: Research
  • Job Type: Full-Time
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