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Clinical Data Systems Analyst eCOA (Hybrid)
Clinical Data Systems Analyst eCOA (Hybrid)AbbVie • Irvine, California, USA
Clinical Data Systems Analyst eCOA (Hybrid)

Clinical Data Systems Analyst eCOA (Hybrid)

AbbVie • Irvine, California, USA
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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

Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments

Engages with members of the DSS and cross-functional study teams in order to effectively execute assigned activities

Effectively utilizes available technology to execute assigned activities

Utilizes data standards (e.g. CDASH and SDTM) in the design and development of key system interfaces and end-to-end data flow

Supports the execution of all processes in support of study startup conduct and close-out

Performs data analyses in support of operational decision support

Supports development of clinical trial application design specifications

May complete rotation through multiple DS roles to establish a base proficiency and to develop a holistic understanding of Data and Statistical Sciences and of clinical development stakeholders

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

Qualifications :

Minimum Qualifications :

  • Bachelors degree in business management information systems computer science life sciences or equivalent.
  • Must have 2 years of clinical research analytics life sciences or comparable experience (or) a masters degree with no previous experience
  • Project Management experience

Preferred Qualifications :

  • Masters degree preferred
  • eCOA experience
  • Other Required Skills :

  • Demonstrated performance as a key contributor to initiatives and advancement of their organization (academic internships or in a previous job)
  • Demonstrated effective communication skills
  • Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively
  • Demonstrated problem-solving and analytical skills
  • Demonstrated leadership traits and ability to influence others without direct authority
  • 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.

    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 :

    No

    Employment Type : Full-time

    Key Skills

    Data Analytics,Microsoft Access,SQL,Power BI,R,Data Visualization,Tableau,Data Management,Data Mining,SAS,Data Analysis Skills,Analytics

    Experience : years

    Vacancy : 1

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    Clinical Data Analyst • Irvine, California, USA

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