
Clinical Data Specialist
2 days ago
The Senior Clinical Data Associate plays a vital role in supporting the clinical trial data management process from start-up to post-database lock for assigned projects under direct supervision.
Key responsibilities include:
- Providing backup support to Lead DM and working as part of a team, ensuring continuity and timely task completion.
- Performing data entry for paper-CRF studies as required.
- Conducting quality control of data entry to maintain accuracy and reliability.
- Assisting in developing CRF specifications from the clinical study protocol and coordinating review/feedback with stakeholders.
The ideal candidate will be responsible for:
- Developing and testing clinical databases to ensure seamless functionality and performance.
- Conducting database build UAT to validate compliance with regulatory requirements.
- Overseeing the overall quality of the clinical database to maintain high standards.
This position requires strong organizational skills and attention to detail, including:
- Coordinating SAE/AE reconciliation to ensure accurate data capture.
- Liaising with third-party vendors to support project timelines and deliverables.
- Presenting software demonstrations/trainings, department/company training sessions, and presenting at project meetings to facilitate effective communication.
The successful candidate will possess:
- A minimum of 5+ years' experience in clinical data management or a related field.
- A Bachelor's degree or equivalent combination of relevant experience.
Desirable skills and qualifications include:
- Experience in a clinical, scientific, or healthcare discipline.
- Medical coding skills, specifically MedDRA and WHODrug.
- An understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
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