AbbVie

Systems Design Analyst I

Employer
AbbVie
Location
Lake County, Illinois
Posted
Nov 19, 2021
Ref
2120380
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

Systems Design Analyst I is responsible for managing the full lifecycle of systems developed by external vendors for individual clinical trial use (e.g. Interactive Voice/Web Response System (IXRS), electronic Clinical Outcomes Assessments (eCOA), image acquisition, etc.). Managing the design, development, validation, implementation, and oversees ongoing support to these systems.
Other responsibilities include the validation of electronic systems and programs as implemented through external vendors according to current regulatory requirements. Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.

Key Duties / Responsibilities
IXRS Lead

  • Responsible for the role which includes managing the IXRS set-up in consultation with the IXRS vendor and the clinical trial team. The IXRS Lead will manage the full lifecycle of IXRS to support various clinical studies. Provides leadership and content expertise working with various stakeholder departments in facilitating and supporting Request For Proposal (RFP), Business Requirements Document (BRD), User Acceptance Testing (UAT), reporting needs, investigator meeting materials, user guide documentation, and study-specific process documents.
  • Responsible for authoring the Business Requirements Document (BRD) and testing documents related to User Acceptance Testing (UAT) for various clinical studies.
  • In addition, the incumbent is the key contact for Clinical Data Management, Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non-Translational Sciences (NTS).

eCOA Lead

  • Responsible for the role which includes managing the eCOA set-up developed by external vendors to support various clinical studies. The eCOA Lead will manage the full lifecycle of eCOA systems to support various clinical studies, and including all the duties and responsibilities of the IXRS Lead.
  • In addition, the incumbent is the key contact for Clinical Data Management, Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non-Translational Sciences (NTS).

Imaging Specialist

  • Responsible for the role which includes serving as an interface between operational study teams and external vendors providing Imaging services. The Imaging Specialist will organize the centralization of imaging objects and ensure controls on the dissemination of images to external groups in accordance with subject consent type. Provides leadership and content expertise working with various stakeholder departments in facilitating and supporting RFPs, image capture protocols, image processing protocols, user requirements documentation, reporting needs, investigator meeting materials, user guide documentation, and study-specific process documents.
  • In addition, the incumbent is the key contact for Clinical Data Management, Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non-Translational Sciences (NTS).

External Vendor Manager

  • Responsible for the role which includes participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable Allergan processes and procedures. Involvement in assessment/re-assessment of vendor capabilities, as necessary.
  • In addition, the incumbent is the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO).

Process Owner/Subject Matter Expert

  • Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out tasks. Drives and/or contributes to continuous improvement. Delivering training to External Data Systems staff and other functions/departments as necessary. Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by External Data Systems staff. Supports Corrective and Preventative (CAPA) Action initiatives as needed.
  • In addition, the incumbent is the key contact for Process, Training, and Continuous Improvement (PTCI) and Global Research & Development Quality (GRDQ).

Qualifications

Minimum Requirements

  • Bachelor’s Degree with demonstrated ability in Clinical Research, Computer Science, Project Management or related field. Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting). Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials.
  • Strong knowledge of global standards related to clinical programming activities (data standards, database design, coding and coding dictionaries, etc.).
  • Strong ability to work in a matrix environment and communicate effectively with different functional groups across the organization.
  • Strong ability to foster open communication and practice active listening to encourage a collaborative team environment.
  • Demonstrates a solution oriented approach to problem solving and a “can do” attitude.
  • Ability to travel up to 15% of time.
  • Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.