BioSpace, Inc.
Design Analyst I (EDC) (On-Site)
BioSpace, Inc., Irvine, California, United States, 92713
Job Details
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
AbbVie Clinical Data Strategy and Operations (CDSO) is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
Resposibilities:Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are usedEnsures that EDC is specified to optimize on functionality, end user experience, and data flowAccountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT)., as well any required changes to EDC. Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutionsEnsures that TA- and program-level consistency is achievedInteracts with and influences DSS and cross-functional team members to achieve program and study objectives.Ensures that assigned work product is synchronized with upstream and downstream dependenciesEnsures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical developmentResponsible for coaching and mentoring CDSO AssociatesParticipates in DSS and cross-functional innovation and process improvement initiativesQualifications
Bachelors degree in business, management information systems, computer science, life sciences or equivalent. Masters preferredMust have 3+ years of clinical technology experience (EDC) or 5+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferredDemonstrated understanding of clinical trial processKnowledge of CDASH and SDTMDemonstrated ability to influence of others without direct authorityDemonstrated effective communication skillsDemonstrated effective analytical skillsAdditional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.This job is eligible to participate in our short-term incentive programs.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
AbbVie Clinical Data Strategy and Operations (CDSO) is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
Resposibilities:Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are usedEnsures that EDC is specified to optimize on functionality, end user experience, and data flowAccountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT)., as well any required changes to EDC. Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutionsEnsures that TA- and program-level consistency is achievedInteracts with and influences DSS and cross-functional team members to achieve program and study objectives.Ensures that assigned work product is synchronized with upstream and downstream dependenciesEnsures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical developmentResponsible for coaching and mentoring CDSO AssociatesParticipates in DSS and cross-functional innovation and process improvement initiativesQualifications
Bachelors degree in business, management information systems, computer science, life sciences or equivalent. Masters preferredMust have 3+ years of clinical technology experience (EDC) or 5+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferredDemonstrated understanding of clinical trial processKnowledge of CDASH and SDTMDemonstrated ability to influence of others without direct authorityDemonstrated effective communication skillsDemonstrated effective analytical skillsAdditional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.This job is eligible to participate in our short-term incentive programs.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html