Senior Clinical Data Manager
New
P
Precision Medicine GroupClinical Research
Location: Remote, MexicoFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 8+ years
Requirements
- Bachelor's degree or equivalent combination of education and experience.
- 8+ years of experience in clinical data management.
- Professional proficiency in English (verbal and written).
- Proficiency in Microsoft Office suite.
- Experience in various clinical database management systems.
- Knowledge of drug, device, and/or biologic development processes.
- Strong leadership, communication, and interpersonal skills.
- Ability to undertake occasional travel.
- Experience with MedDRA and WHODrug coding (preferred).
- Understanding of CDISC standards like CDASH, SDTM, and ADaM (preferred).
- Oncology and/or Orphan Drug therapeutic experience (preferred).
Responsibilities
- Serve as primary Data Management (DM) lead for assigned clinical projects.
- Oversee project data entry process and ensure DM deadlines are met.
- Develop CRF specifications and coordinate stakeholder feedback.
- Conduct database build UAT and maintain documentation.
- Specify requirements for edit checks and manual data review.
- Review and query clinical trial data according to the Data Management Plan.
- Perform medical coding and coordinate SAE/AE reconciliation.
- Liaise with third-party vendors and EDC vendors.
- Troubleshoot operational problems based on metrics and audit reports.
- Train clinical research personnel on study-specific items.
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