Clinical Data Manager
Clinical Data Manager
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Salary Not Disclosed
1 Vacancy
Job Description
- Support the end-to-end clinical data management process for assigned studies from protocol review to database lock.
- Collaborate with cross-functional teams including clinical operations biostatistics and medical writing to define data collection and reporting needs.
- Review and finalize clinical data management documentation such as Data Management Plans (DMP) Case Report Forms (CRFs) and data validation specifications.
- Ensure adherence to applicable regulatory guidelines (e.g. FDA ICH GCP) and company standards for data management.
- Perform data cleaning query resolution and reconciliation of external data sources (e.g. lab data ePRO).
- Support database setup testing and maintenance in partnership with external vendors or internal teams.
- Perform quality control and audit activities to ensure data accuracy and compliance.
- Support data reviews and provide metrics and status updates to project teams and leadership.
Requirements:
- Bachelors degree in Life Sciences Computer Science or a related field.
- Minimum of 3 years of clinical data management experience in the pharmaceutical biotech or CRO industry.
- Proficiency in electronic data capture (EDC) systems such as Medidata Rave Oracle Clinical or similar platforms.
- Strong knowledge of CDISC standards including SDTM and ADaM.
- Excellent understanding of clinical trial processes and regulatory requirements (e.g. FDA EMA).
- Exceptional attention to detail and problem-solving skills.
- Ability to work independently and communicate effectively with diverse stakeholders.
Employment Type
Full-time
