349232BR
Jul 19, 2022
USA

Job Description

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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.
In this role you will be responsible for testing clinical trial patient specimens according to validated GCLP protocols. Utilize technical and scientific expertise in immunophenotyping to analyze and review high dimensional flow cytometry data collected from immuno-oncology clinical trials. Candidate should exhibit moderate to high level of independence while working on multiple projects.


JOB PURPOSE & IMPACT
This position will be primarily responsible for leading projects related to data entry and QC of LIMS within the FlowCore of the Flow Cytometry Department. The Sr. Data Specialist will also assist in directing other Data Specialists and placing reagent/lab orders on behalf of the Flow Cytometry Department. This position will report to the FlowCore Manager.

The Data Specialist subgroup reports to the FlowCore Manager. This subgroup is responsible for entering all data that is generated by the Flow Cytometry department into LIMS and ensuring accuracy and adherence to applicable regulations. The Data Specialist subgroup is also responsible for all reagent/lab ordering on behalf the Flow Cytometry department. This subgroup will provide the Flow Cytometry Department constant communication on updates and progress related to data and ordering.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Note: Other duties may be assigned.
• Mentors, organize, and trains Data Specialist subgroup within FlowCore.
• Reports to FlowCore Manager within Flow Cytometry Department.
• Performs accurate entry of clinical trial data into computer database(s), electronic worksheets and LIMS in accordance with project requirements.
• Exceptional attention to detail in verifying data entered into the various systems by checking printouts/reports for errors and corrects as required.
• Reviews and verifies source materials to determine accuracy and completeness of information; follows up to correct or complete data entries.
• Identification and correction of data errors in accordance with quality assurance procedures.
• Adheres to standard operating procedures, protocols, and study specific guidelines.
• Adheres to data security and confidentiality requirements when handling confidential data.
• Data entry tasks for multiple clinical studies.
• Manual data entry review.
• Communicates with flow cytometry staff and tech leads regularly on data entry and data management issues.
• Provides status updates on data entry tasks to management as necessary.
• Ability to process and prioritize relevant tasks efficiently.
• Peer-to-peer quality review to ensure data integrity.

OTHER RESPONSIBILITIES
• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions
• Ensuring change requests are properly 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


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Diversity & Inclusion / EEO

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

Qualifications
• Excellent communication skills necessary to deal effectively with co-workers and all levels of laboratory staff.
• Ability to communicate clearly and concisely in writing and verbal.
• A willingness to work in a fast paced, high volume environment.
• Able to perform basic math functions and accurate data entry.
• Demonstrated excellent organizational, time management, and multitasking skills.
• Impeccable attention to detail.
• Highly motivated self-starter.

Education and Experience
• Education: Bachelor's degree in technology science or health-related field from an accredited institution is a plus.
• Years of Experience Required: Minimum of one (1) year data management experience preferred.
• Data entry experience preferred.
• Demonstrated proficiency in data entry and computer software applications (MS Word, Excel, Outlook).

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
NAVIGATE BIOPHARMA SERVICES
USA
Carlsbad, CA
Research & Development
Full Time
Regular
No
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349232BR

Sr. Data Specialist

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