Manager, Clinical Data Systems

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

AbbVie Data Science 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.

Responsibilities:

Actively participates in the development of common data standards and ensures systems designs comply with the standards as well as with associated protocol requirements. Ensures that the design team utilizes standards
Establishes and maintains methodology used by the team to design and develop clinical trial systems benchmarking against industry standards. Ensures that systems are specified to optimize on functionality end user experience and data flow. Ensures that the design team meets these expectations
Ensures that TA- and program-level consistency is achieved by the design team
Accountable for the on-time design and delivery of new clinical systems integrations between systems as well any required changes to clinical systems (e.g. EDC IRT ePRO). 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 solutions
Interacts 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 dependencies
Ensures 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 development
Responsible for coaching and mentoring members of the team as well as contributes to their skill development
Leads DSS and cross-functional innovation and process improvement initiatives

Qualifications :

Bachelors degree in business management information systems computer science life sciences or equivalent. Masters preferred.
Must have 5 years of clinical technology experience (e.g. EDC IRT ePRO) or 7 years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools required.
In-depth knowledge of clinical trial process.
In-depth knowledge of CDASH and SDTM.
Demonstrated performance as a key contributor to initiatives and advancement of the organization.
Demonstrated ability to influence others without direct authority.
Demonstrated ability to successfully coach / mentor in a matrixed environment.
Demonstrated effective communication skills and analytical skills.

Additional 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 in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay 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/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Responsibilities:

Actively participates in the development of common data standards and ensures systems designs comply with the standards as well as with associated protocol requirements. Ensures that the design team utilizes standards
Establishes and maintains methodology used by the team to design and develop clinical trial systems benchmarking against industry standards. Ensures that systems are specified to optimize on functionality end user experience and data flow. Ensures that the design team meets these expectations
Ensures that TA- and program-level consistency is achieved by the design team
Accountable for the on-time design and delivery of new clinical systems integrations between systems as well any required changes to clinical systems (e.g. EDC IRT ePRO). 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 solutions
Interacts 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 dependencies
Ensures 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 development
Responsible for coaching and mentoring members of the team as well as contributes to their skill development
Leads DSS and cross-functional innovation and process improvement initiatives

Qualifications :

Bachelors degree in business management information systems computer science life sciences or equivalent. Masters preferred.
Must have 5 years of clinical technology experience (e.g. EDC IRT ePRO) or 7 years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools required.
In-depth knowledge of clinical trial process.
In-depth knowledge of CDASH and SDTM.
Demonstrated performance as a key contributor to initiatives and advancement of the organization.
Demonstrated ability to influence others without direct authority.
Demonstrated ability to successfully coach / mentor in a matrixed environment.
Demonstrated effective communication skills and analytical skills.

Additional 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 in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay 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/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Key Skills

SQL
Data Collection
GCP
Master Data Management
R
Data Management
Clinical Trials
User Acceptance Testing
Data Warehouse
SAS
Oracle
Data Analysis Skills

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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