348254BR
Jul 06, 2022
USA

Job Description

We are looking for an innovative and resourceful individual who will be responsible for developing and maintaining real-time transfer of critical non-clinical study data from contract research laboratories and other external partners into Novartis data systems. The optimal candidate will facilitate visualization and data mining opportunities to answer key scientific questions. Key responsibilities will include: representing Novartis in discussions with external partners, comprehend and simplify complex data transfer process(es), fulfill stakeholder data needs, identify, define and resolve database gaps and drive process efficiency to achieve complete high quality data sets. Troubleshooting to mitigate/minimize the occurrence of incomplete and/or inaccurate data capture is also within scope.

Your responsibilities:

•Collaboratively refine processes to ensure accurate and complete scientific data transfer from non-clinical safety studies to Novartis Study Data Warehouse (quality control)

a. Align Preclinical Safety and DMPK data requirements with protocols, reports, etc. in close collaboration with Study Directors/Leads/ Subject-Matter Experts.
b. Evaluate quality and accuracy of non-clinical data received from external partners and liaise with same to resolve discrepancies with corrective actions where needed
c. Ensure timely delivery of CDISC-SEND compliant study data from external test sites and contributing scientists to the Novartis Study Data Warehouse

•Establish a multidisciplinary hub for the data transfer process, from preclinical/non-clinical studies to ensure database completeness and accuracy
a. Partner with different Preclinical Safety and DMPK line functions to define the purpose, need and precise details to be included for data collection and documentation
b. Ensure external partners deliver on the needs, processes, corrective actions and related communication in topics related to the data transfer process.
c. Ensure Novartis scientists deliver high quality data to external partners in a timely manner.
d. Drive strategy of including new data types or sources, e.g., genomics, transcriptomics, immunophenotyping in the Novartis Study Data Warehouse, according to emerging needs from Preclinical Safety, Regulatory requirements, etc. Represent Novartis on industry wide teams to impact/ influence regulatory policies
•Liaise with Preclinical Safety scientists and Study Monitors to ensure the data obtained is of acceptable quality
•Coordinate with Preclinical Safety management and operations to define goals, objectives and Key Performance Indicators to include in contracts/expectation documents with external partners
•Develop expertise using standard and in-house developed data handling and presentation tools

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

What you’ll bring to the role:
•The role can be based remotely
•Bachelor’s degree with 5 years’ experience in preclinical safety /research laboratories, or Master’s degree with 3 years preclinical safety /research laboratories experience
•Leading in a matrix environment
•Experience working with large data sets especially from the pharmaceutical industry for example (clinical pathology, in-life findings, Toxicokinetic, pathology, genomics, etc.)

Desirable:
•Effective organizational skills (planning, training, time management, etc.)
•Excellent interpersonal and communication skills
•Competence with Business Intelligence data visualization tools (ex: Spotfire, Qlik), basic scripting experience (Python, R) recommended
•Thorough understanding of operations/procedures/equipment in the respective discipline (e.g. toxicology, clinical pathology, data curation and management)
•Broad understanding of scientific and technical operations in Preclinical Safety and DMPK
•Familiarity with CDISC SEND data
•Computer skills including data entry/auditing in system software, and strong skills in Microsoft windows-based software.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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!

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

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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
NIBR
Translational Medicine
USA
Cambridge, MA
Research & Development
Full Time
Regular
No
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348254BR

Pre-clinical Data Manager

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