Responsible for centrally reviewing clinical study data to ensure high quality data are available for regulatory submissions, safety monitoring, contracted deliverables and publications. Ensures study data is being collected in compliance with study protocols. Determines root cause for data quality problems in order to resolve data issues.
This role ensures the integrity of data collected in multiple research databases by generating queries to study sites, resolving data issues, and ensuring data quality checks and centralized data review processes are technically accurate and adhere to established business and clinical study requirements.
Must communicate well with peers, study teams and management as appropriate to support studies and goals.
Collaborates with study teams to translate clinical study needs into analytics/reporting requirements. This includes processes for error identification, determining data quality thresholds, output generation, testing and generating documentation.
Communicates with study sites to resolve data quality issues. Escalates issues of continuing data non-compliance to Clinical Project Manager and other study team members as appropriate.
Analyzes data, identifies trends; prepares data tables for reports.
Has a greater understanding of study case report form development, validations, database and data quality check design.
Performs EDC UAT
Other duties as assigned.
Research/clinical databases, such as registries using electronic data capture (EDC) systems.
Highly skilled with MS Office, especially Excel.
Excellent understanding of databases; excellent technical skills in querying and analyzing data.
Strong knowledge of GCP and ICH guidelines.
Organized and thorough with attention to details.
Effective in interpersonal skills and have excellent verbal, written and listening communication skills.
Effective in logical thinking and problem solving.
Manage multiple deadlines and priorities while ensuring quality and timeliness.
Bachelor’s degree in one of the life sciences, Health Information Management, Health Information Technician, or equivalent knowledge and experience.
Minimum two years of relevant experience in data analysis, data management or in a clinical research environment.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
Knowledge of blood and marrow transplant clinical research and medical field.
Holds relevant SCDM, ACRP, or SOCRA certification.
Telecommuting is allowed.
Internal Number: 2000008D
About Be The Match
Our Mission: We save lives through cellular therapy.
Our Vision: Democratize cell therapy. Equal outcomes for all.
For people with life-threatening blood cancers — like leukemia and lymphoma— or other diseases like sickle cell, a cure exists.
Be The Match connects patients with their donor match for a life-saving blood stem cell transplant. Be The Match provides patients and their families one-on-one support, education, and guidance before, during and after transplant.