Offer summary

Qualifications:

Bachelor’s degree in a related field preferred., 3 years of experience in clinical research using eCOA-like systems., Excellent computer skills with understanding of clinical systems and data administration., Ability to program using languages such as JSON..

Key responsabilities:

Build and administer Celerion databases within the eCOA environment.

Coordinate licensing for surveys/questionnaires and create test data/scripts.

Manage the deployment of eCOA trials and setup interface connections with other systems.

Ensure completeness and correctness of eCOA design, data extracts, and clinical data.

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Celerion is hiring for a full-time remote Veeva eCOA Database Developer in the United States. Travel is required domestically and/or internationally for this position.

Job Purpose:

Build and administer Celerion databases within the eCOA environment for protocols, eCRF design and build with corresponding edits as well as subsequent database administration such as user access, mid-study changes and data exports/reports. Position will also serve as lead in accepting Veeva eCOA updates/upgrades, ensuring validation and User Acceptance Testing (UAT) is complete per SOP prior to an eCOA change being pushed to the production instance. Responsible for working collaboratively as programming contact with Clinical Data Managers, Biostatisticians, Clinical and Project Management staff and Sponsors to meet project deliverables, timelines and budgets for eCOA clinical data acquisition, quality checking and reporting while adhering to relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.

Essential Functions:

Perform all activities related to eCOA design and build programming for assigned projects including preparing eCOA specifications and any special licensing that is required for the survey/questionnaire.

Coordinate licensing if needed for any survey/questionnaires.

Create test data / scripts to test both the screen design and validation checks

Create, build and maintain programmatic/functional template libraries and utlilize templates as necessary to speed development

Perform ad-hoc programming support such as listing and reports creation using clinical reporting tools within the eCOA

Provide timely support to the study team on all programming matters according to the project plan and programming specification using internal, standards and guidelines.

Ensure completeness, correctness and consistency of eCOA design, data extracts and listings, and clinical data and data structure

Maintain global clinical trial database standards (CDISC)

Troubleshoot problems on eCOA system, escalate to IT and vendor as needed

Manage the deployment of eCOA trials and setup interface connections between eCOA and other systems, including complex deployments and study specific configurations

Contribute to special projects to meet the business needs from internal and external groups

Author and review procedures and work instructions

Coordinate upgrades of hardware/software including validation documentation development, review and execution

Setup test system environments and coordinate project team members for execution of test scripts

Create validation documentation according to Celerion SOPs and move these documents through the completion, review and approval process

Knowledge/Skills/Education/Licenses:

Bachelor’s degree in related field preferred

3 years or equivalent experience in clinical research using eCOA-like systems to collect data and report

Excellent computer skills with understanding of clinical systems and data administration

Ability to program using appropriate languages such as JSON

Ability to organize and manage multiple concurrent priorities required

Excllent oral and written communication required

Excellent organizational skills required

Problem solving skills required

Celerion Values: Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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