Systems Design Analyst I, Ecoa / Epro (On-Site)

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

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Creates the clinical technology design specifications (e.g., EDC, IRT, ePRO) for all assigned trials Creates the data cleaning plan for all assigned trials

• Manages the work of the Query Analyst, or an outsourced trial support team, in the execution of the data cleaning plan Updates the data cleaning plan as necessary during trial conduct for all assigned trials Manages the execution of all DSS processes involved in the locking of the trial database for assigned trials Liaises with the study team. Effectively communicates progress and expectations around DM Operations processes and the health of the Study

• Accountable to correctly implement the design of the protocol into the clinical technology design specifications for all assigned trials Accountable to produce a data cleaning plan that, when executed as designed, will produce a clinical-trial database that is fit for purpose and adequate for statistical analysis. Accountable for the timely application and implementation of the data cleaning plan across the data collected for assigned trials.

• Accountable for the lock of assigned trial databases in a regulatory-compliant manner and in accord with DS SOPs, process design and timelines Accountable for supporting and utilizing Data Sciences policies and procedures.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

This position is required to sit on-site 3 days / week

• Must have 4+ years of direct data management experience or 6+ years of experience in a similar technical environment

• Must have experience designing systems and creating system specifications.

• Must have experience using analytics tools Must have demonstrated experience in influencing teams during the design, conduct, and completion of trials

• Must have demonstrated ability to convert statistical analysis needs to data requirements. Demonstrated effective communication skills.

• Must demonstrate analytical skills and ability to identify signals and potential issues with clinical data, and development of plans to address

Additional Information

Applicable only to applicants