About the Role
Divine AG Solutions Limited (RC 1243335) is recruiting a detail-oriented and experienced Clinical Data Associate to join our expanding team. In this pivotal role, you will be responsible for coordinating data management activities throughout clinical trials, ensuring the overall quality, accuracy, and integrity of data inputs and outputs. You will work closely with clinical research associates, project leaders, and sponsors to support successful trial outcomes while upholding our core values of integrity, reliability, and professionalism.
Key Responsibilities- Independently review clinical study data entered in EDC systems, generate queries, and collaborate with site staff to ensure accurate reporting.
- Draft data-related manuals and plans, including Data Management Plans, eCRF Completion Guidelines, and Data Validation Specifications.
- Perform database User Acceptance Testing, script writing, and execute database user administration tasks.
- Maintain and track monthly clinical research project data metrics, identifying trends in partnership with the Clinical Data Manager.
- Assist with data coding, medical term maintenance using WHODrug and MedDRA, and data reconciliation for SAEs and external labs.
- Represent the Clinical Data Management department in sponsor meetings, audits, and cross-functional project team collaborations.
- Associate's Degree or higher, with strong preference for fields in Health Sciences, Statistics, or Data Management.
- Minimum of 4 years of data coordination or data management experience within a pharmaceutical, biotechnology, academic, or contract research organization.
- Hands-on experience with commercial Electronic Data Capture (EDC) systems such as Medidata Rave or Oracle Inform.
- Demonstrated knowledge of the clinical drug development process and clinical study database design.
- Strong problem-solving, strategic thinking, and exceptional written and verbal communication skills.
- Competitive salary package commensurate with experience and industry standards.
- Opportunities for professional growth and continuous learning within the healthcare outsourcing sector.
- Collaborative, supportive, and dynamic work environment in a reputable organization.