Senior Clinical Data Manager

7 giorni fa


Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno
Senior Clinical Data Manager

Fortrea Drug Development is seeking a highly skilled Senior Clinical Data Manager to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions.

About the Role

The Senior Clinical Data Manager will be responsible for providing leadership and operational expertise in the strategic planning and delivery of Clinical Data Management (CDM) deliverables at program and/or project level. This includes management and oversight of vendor contracts, resourcing, and budget management, as well as oversight of vendor performance for assigned programs and projects.

Key Responsibilities
  • Provides CDM leadership for one or more assigned projects or indications, taking global accountability and serving as the second line of contact at the project level.
  • Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level.
  • Communicates and negotiates effectively with all other Program level team members, serving as the primary point of contact for Clinical Data Management (CDM).
  • Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
  • May act as a team leader or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
Requirements
  • University/college degree (life science, pharmacy, or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution.
  • Experience in leading complex oncology clinical trials.
  • Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting.
  • Excellent oral and written communication and presentation skills.
  • In-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
About Fortrea Drug Development

Fortrea is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.



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