Clinical Data Manager
J
JobgetherClinical Research
BrazilFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 8 years of clinical data management experience for Senior-level positions or 10+ years for Principal-level positions.
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree or an equivalent combination of relevant education and professional experience.
- At least 8 years of clinical data management experience for Senior-level or 10+ years for Principal-level.
- Proven experience with clinical database management systems and trial data management processes.
- Broad understanding of drug, medical device, and/or biologic development practices.
- Professional proficiency in English, with strong written and verbal communication skills.
- Strong proficiency in Microsoft Office, particularly Word, Excel, PowerPoint, and Outlook.
- Strong organizational and time management abilities for managing multiple research activities.
- Strong analytical and problem-solving skills to assess data and resolve inconsistencies.
- Demonstrated leadership and interpersonal skills for cross-functional team coordination.
- Experience with medical coding dictionaries such as MedDRA and WHODrug (preferred).
- Knowledge of CDISC standards including CDASH, SDTM, and ADaM (preferred).
- Ability to work independently in a collaborative, international project environment.
Responsibilities
- Serve as the primary Data Management contact for assigned clinical projects or programs.
- Oversee clinical data entry processes, quality control, and training.
- Develop and maintain Case Report Form (CRF) specifications and coordinate stakeholder reviews.
- Support or oversee clinical database development, user acceptance testing, and documentation.
- Review and query clinical trial data according to Data Management Plans.
- Monitor patient- and study-level metrics to identify and address operational risks.
- Coordinate adverse event reconciliation and medical coding activities.
- Liaise with external EDC vendors and support financial and operational planning.
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