Clinical Data Management Associate

hace 3 semanas


San José, San José, Costa Rica Microport Orthopedics Sa A tiempo completo

About the Role

We are seeking a highly skilled Clinical Data Management Associate to join our team at MicroPort Orthopedics Sa. As a key member of our clinical operations team, you will be responsible for ensuring the integrity and quality of clinical trial data.

Key Responsibilities

  • Act as the primary or supporting data manager responsible for study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing.
  • Participate in and lead data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
  • Participate in and lead the data management plan (DMP) development and maintenance.
  • Ensure that user administration in data management-owned systems and Trial Master File document filing is accurate and timely.
  • Manage the planning, implementation, and overall direction of executing clinical trial data management activities, including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management.

Requirements

  • Computer experience with databases and spreadsheet software.
  • Understanding of database structure and processes in data management.
  • Basic knowledge of medical terminology and clinical research methodologies.
  • Knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.).
  • Current computer literacy in appropriate software (i.e., recent versions of Microsoft Office software suite).
  • Excellent interpersonal, written, and oral communication skills.
  • Fluency in English - written and verbal (B2+ or above).
  • Accuracy and attention to detail.
  • Thorough and proven understanding of the principles of data management and administration.
  • Proven ability to advise on data management strategies development, detail-oriented focus, and strong analytical thinking skills.

About MicroPort Orthopedics Sa

We are a dynamic and inclusive company that welcomes motivated and talented people who want to join our team. We hold to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. We strive to master every detail of our medical solutions to prolong and reshape patients' lives everywhere.



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