Accountabilities:
Lead and coordinate non-CRF data management activities across study setup, conduct, and closeout phases for global clinical trials.
Ensure accurate integration and reconciliation of external data sources (lab, eCOA, ePRO, devices, IRT/IVRS, etc.) with clinical databases.
Perform User Acceptance Testing (UAT), post-migration testing, and validation of data entry screens, edit checks, and system configurations.
Manage data cleaning activities, discrepancy reviews, query resolution, and quality control checks across EDC and paper-based studies.
Support database setup activities including CRF/eCRF review, DVS input, edit checks, and study-specific documentation creation.
Oversee vendor data transfers, agreements, and specifications to ensure alignment with study requirements and compliance standards.
Act as SME and mentor for CDA team members, supporting training, work review, and capability development across projects.
Participate in audits, stakeholder meetings, and cross-functional discussions to ensure transparency and data quality compliance.
Requirements:
5–7 years of experience in Clinical Data Management, with strong exposure to non-CRF and external vendor data setup.
Hands-on experience with clinical trial systems such as Oracle Clinical, Medidata Rave, or Inform (preferred).
Strong knowledge of clinical data management processes, ICH-GCP guidelines, and clinical trial lifecycle activities.
Experience working with external data sources such as central labs, eCOA/ePRO, ECG, devices, sensors, and IRT/IVRS systems.
Solid understanding of UAT, data validation, edit checks, data reconciliation, and database testing processes.
Strong analytical, problem-solving, and data quality management skills with high attention to detail.
Excellent communication and stakeholder management skills, with ability to collaborate across global teams.
Ability to multitask, manage priorities under tight deadlines, and work independently in a regulated environment.
Preferred: Degree in life sciences, biology, healthcare, or related scientific field.
Benefits:
Competitive compensation aligned with experience and industry standards
Remote-friendly or hybrid work flexibility depending on project requirements
Comprehensive health, medical, and life insurance coverage
Opportunities to work on global clinical trials and innovative drug development programs
Strong learning culture with training, certifications, and career development support
Exposure to advanced clinical data systems and cutting-edge research technologies
Inclusive, collaborative, and globally connected work environment
Opportunities to mentor, lead initiatives, and grow into senior leadership roles.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
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