Associate Clinical Data Manager - (Remote)
- Location
- Carlsbad, CA
- Posted
- Jun 10, 2022
- Ref
- 344989BR
- Discipline
- Clinical, Clinical Data, Clinical Research
- Hotbed
- Biotech Beach
- Required Education
- Bachelors Degree
- Position Type
- Full time
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.
Local candidates preferred.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
RESPONSIBILITIES:
- Work in a GMP/GCP/GLP/CLIA regulated environment and follow all applicable regulations
- Perform end-to-end delivery of data management services for multiple clinical trial projects with some guidance, ensuring quality deliverables on time
- Perform routine quality control of data for multiple complex clinical trial projects at various stages of data handling to ensure that all data are reliable and have been processed accurately (e.g., quality check of source data, databases and reports as required).
- Establish strong communication with GxP team, test method leads, project managers and all other collaborators
- Connect with Project Managers, GxP team and technical leads on a regular basis to meet data management deliverables for multiple projects and ensure achievements meet timelines and quality deliverables
- With minimal guidance, support Clinical Data Management (CDM) team with comprehensive CDM process and technical expertise in carrying out data projects
- Perform data remediation and other efforts related to researching and updating incomplete or missing information
- Perform extraction of data and generate required reports as requested
- Work with project team to identify and resolve data issues
- May perform data entry of a significant amount of information from electronic or hardcopy source materials such as patient demographics, clinical raw data and testing results into electronic databases and spreadsheets in accordance with project requirements as necessary
- Reviews and verifies source materials to determine accuracy and completeness of information; follows up to correct or complete data
- Assist with identification and correction of data errors in accordance with quality assurance procedures
- Assist with study close-out activities to verify data integrity and data completeness
- With guidance, prepares data validation documents and conducts data validation testing
- Provide status updates related to project tasks to management as necessary
- Assist with preparing or reviewing work instructions.
- Assist with preparing requirement/qualification documents and qualification testing for MIRTH channels.
- 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 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.
- Bachelor degree with 2 years of direct Clinical Data Management experience
- Knowledge of biomarker data and clinical data related to clinical trials
- Demonstrated experience in data management and computer software applications (MS Word, Excel, Outlook)
- Background in handling various types of laboratory generated data across various molecular and protein based platforms
- Experience in auditing clinical data for accuracy and compliance
- Knowledge of GCP guidelines and clinical trials
- Effective verbal communications skills
- Ability to focus and complete repetitive tasks for an extended period of time
- Strong time-management skills
- Strong attention to detail and accurate data entry
- Flexibility and capability to multitask and meet established deadlines
- Ability to prioritize and work with minimal direction
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] Division ONCOLOGY Business Unit NAVIGATE BIOPHARMA SERVICES Location USA Site Carlsbad, CA Company/Legal Entity Navigate BioPharma Svcs., Inc. Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
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.
Local candidates preferred.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
RESPONSIBILITIES:
- Work in a GMP/GCP/GLP/CLIA regulated environment and follow all applicable regulations
- Perform end-to-end delivery of data management services for multiple clinical trial projects with some guidance, ensuring quality deliverables on time
- Perform routine quality control of data for multiple complex clinical trial projects at various stages of data handling to ensure that all data are reliable and have been processed accurately (e.g., quality check of source data, databases and reports as required).
- Establish strong communication with GxP team, test method leads, project managers and all other collaborators
- Connect with Project Managers, GxP team and technical leads on a regular basis to meet data management deliverables for multiple projects and ensure achievements meet timelines and quality deliverables
- With minimal guidance, support Clinical Data Management (CDM) team with comprehensive CDM process and technical expertise in carrying out data projects
- Perform data remediation and other efforts related to researching and updating incomplete or missing information
- Perform extraction of data and generate required reports as requested
- Work with project team to identify and resolve data issues
- May perform data entry of a significant amount of information from electronic or hardcopy source materials such as patient demographics, clinical raw data and testing results into electronic databases and spreadsheets in accordance with project requirements as necessary
- Reviews and verifies source materials to determine accuracy and completeness of information; follows up to correct or complete data
- Assist with identification and correction of data errors in accordance with quality assurance procedures
- Assist with study close-out activities to verify data integrity and data completeness
- With guidance, prepares data validation documents and conducts data validation testing
- Provide status updates related to project tasks to management as necessary
- Assist with preparing or reviewing work instructions.
- Assist with preparing requirement/qualification documents and qualification testing for MIRTH channels.
- 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 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.
- Bachelor degree with 2 years of direct Clinical Data Management experience
- Knowledge of biomarker data and clinical data related to clinical trials
- Demonstrated experience in data management and computer software applications (MS Word, Excel, Outlook)
- Background in handling various types of laboratory generated data across various molecular and protein based platforms
- Experience in auditing clinical data for accuracy and compliance
- Knowledge of GCP guidelines and clinical trials
- Effective verbal communications skills
- Ability to focus and complete repetitive tasks for an extended period of time
- Strong time-management skills
- Strong attention to detail and accurate data entry
- Flexibility and capability to multitask and meet established deadlines
- Ability to prioritize and work with minimal direction
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] Division ONCOLOGY Business Unit NAVIGATE BIOPHARMA SERVICES Location USA Site Carlsbad, CA Company/Legal Entity Navigate BioPharma Svcs., Inc. Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No