• Responsible for data management activities including, but not limited to, developing data management plans, department SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trials databases.

Essential Duties AND Responsibilities:

• Designs clinical trial specific subject Case Report Forms for use in e-clinical EDC systems.
• Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
• Designs and validates clinical databases including designing logic checks, UAT etc.
• Programs SAS edit checks and SAS macros for clinical trials, encompassing ETL processes, data validations, statistical analyses, and report generation.
• Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g., Marketing questionnaires) collected during clinical studies.
• Responsible for filing and maintaining digital data collected during clinical studies.
• Conduct data automation tasks, including software development, testing, and validation. Familiarity with Power BI, R, Python, HTML, JavaScript, and REST APIs for data downloading is a plus.
• Knowledge of the software development life cycle (SDLC) and experience in coding and design.
• Summarizes basic elements for clinical databases periodically.
• Communicates with end users to define or implement clinical data management requirement for the clinical study such as data release, delivery schedules, and testing protocols.
• Provides training and technical support to clinical site personnel on EDC for specific studies.
• Maintains more than 3 study databases and data management activities concurrently. Ability to multi-task while still being detail oriented.
• Develops project-specific data management plans that address areas such as data reporting, transfer, database lock and work flow.
• Monitors work quality to ensure compliance with standard operating procedures.

Required Skills (top 3 non-negotiables):

• Strong expertise in SAS program and SAS macros
• Data Automation system
• Design and maintain clinical databases in EDC.

Preferred Skills (nice to have):

• Create CRF and Data management documentation
• Data visualization tools (Power BI)
• R or Python

Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience

Software Skills Required:

• SAS
• SQL
• R
• Python

Required Certifications** : SAS base certification

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.