This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr CDA (Data Acquisition Specialist – Non-CRF) based in India.
You will play a critical role in enabling high-quality clinical data acquisition across global clinical trials, ensuring the integrity and accuracy of non-CRF data throughout study lifecycles.
This role operates within a highly regulated and fast-paced clinical research environment, supporting complex drug development programs that directly impact patient outcomes.
You will collaborate with cross-functional teams, including data management, clinical operations, and biostatistics, to ensure seamless integration of external and internal data sources.
A key part of your work will involve leading and coordinating non-CRF data activities, ensuring timely delivery, compliance, and quality across multiple studies.
You will also contribute to system setup, testing, and validation processes for clinical databases and external vendor data streams.
In addition, you will act as a mentor and SME, supporting less experienced team members and driving best practices in clinical data management.
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.
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