Data Management Coordinator

4 giorni fa

Italia Opis S.r.l. A tempo pieno

As a Data Manager Project Coordinator , you will report directly to the Director of Data Management and oversee data management activities across a diverse range of clinical projects. Your leadership will ensure timely, accurate, and regulatory-compliant data delivery while driving innovation through advanced tools and technologies.

Some of what you'll do:

  • Supervise and coordinate the activities of the Data Management team.
  • Ensure data management processes comply with applicable standards, guidelines, and company SOPs.
  • Lead start-up activities, including CRF design, UAT, and edit check reviews, and ongoing data management tasks like data cleaning and reconciliation.
  • Prepare, review, and oversee study-specific documents such as Data Management Plans and eCRF Completion Guidelines.
  • Act as the primary contact for sponsors and external stakeholders, ensuring smooth project collaboration and communication.
  • Monitor project timelines and deliverables, ensuring they are met with the highest quality standards.
  • Drive the adoption of innovative digital tools to enhance data processing and management efficiency.
  • Mentor and train junior staff, fostering a culture of growth and learning.
  • Participate in client meetings, including bid defenses, project kick-offs, and investigator sessions.
  • Support audits, inspections, and CAPA plan implementations to ensure compliance and readiness.

Some of what you have:

  • Bachelor’s degree educated preferred.
  • At least 12 years in CRO, biotech, or pharmaceutical environments, or 3 years in a similar leadership role.
  • Strong understanding of ICH-GCP/ISO14155 and HA regulations for clinical research.
  • Expertise in relational databases, SAS systems, and FDA 21 CFR Part 11 compliance.
  • Experience with CDISC standards, including SDTM.
  • Proven project management and problem-solving capabilities.
  • Leadership, organizational, and communication skills.
  • Proficiency in English.

What we offer:

We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

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