About the Role
We are seeking an experienced and detail-driven Data Manager to join our clinical research operations team. In this role, you will lead and coordinate data management activities across global clinical trials to ensure high-quality, accurate, and regulatory-compliant data. The ideal candidate will possess strong technical expertise and a collaborative spirit to work effectively with cross-functional teams in a remote environment.
Requirements
Proven track record managing data for Phase I–IV clinical trials.
Hands-on experience with EDC system configuration and UAT.
Understanding of data privacy and protection regulations (e.g., GDPR, HIPAA).
Ability to manage timelines across multiple studies simultaneously.
Commitment to maintaining data quality and supporting data-driven decisions.
Qualification
Bachelor’s degree in Life Sciences, Health Information Management, Computer Science, or a related field.
At least 5 years of clinical data management experience in a CRO, biotech, or pharmaceutical setting.
Proficient with leading EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva Vault).
Familiarity with CDISC standards (CDASH, SDTM) and regulatory compliance (ICH-GCP, FDA, EMA).
Strong organizational and analytical skills with attention to detail.
Excellent communication skills, both written and verbal.
Comfortable working independently in a remote and fast-paced environment.
Responsibilities
Lead and manage all data management activities from study start-up through database lock.
Develop study-specific Data Management Plans (DMPs), CRFs, edit check specifications, and data review guidelines.
Oversee EDC system setup, testing, and maintenance; ensure timely resolution of technical issues.
Generate and resolve data queries in collaboration with clinical monitors and site personnel.
Ensure data consistency and compliance with regulatory standards, including CDASH and SDTM.
Perform ongoing data cleaning and validation to support timely and accurate statistical analysis.
Participate in audits and contribute to the development of SOPs and process improvements.