Associate Principal Engineer - Clinical Data Manager

Company Description

We are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale — across all devices and digital mediums, and our people exist everywhere in the world (19000+ experts across 37 countries, to be exact). Our work culture is dynamic and non-hierarchical. We are looking for great new colleagues. That is where you come in!

Job Description

Must have Skills : Clinical Data Management, DMP and eCRF designing, CDISC and STDM Implementation, ICH/GCP guidelines,

Job Description :

We are looking for a Clinical Data Manager (CDM) with experience in the implementation of clinical data standards per CDISC/SDTM. Below are the skillset required.

1. Design and Implement Data Management Plans (DMPs):
   • Collaborate with cross-functional teams to create comprehensive DMPs that outline data collection, validation, and quality control processes throughout clinical trials. Define data entry guidelines and standards to ensure consistent and accurate data capture.
2. Database Design and Maintenance:
   • Oversee the development and maintenance of clinical trial databases (DBs). Work closely with IT teams to design efficient and user-friendly electronic data capture (EDC) systems. Ensure that DBs comply with regulatory requirements and industry best practices.
3. Data Quality Control and Consistency:
   • Implement robust quality control processes to validate and clean clinical trial data. Monitor data consistency across different systems and resolve discrepancies promptly. Collaborate with clinical research associates, biostatisticians, and other team members to address data-related issues.
4. Documentation and Compliance:
   • Maintain accurate and detailed database log documents. Adhere to Good Clinical Practice (GCP) guidelines and other regulatory standards. Having GCP certification is considered advantageous.