Clinical Business Operations (Contracts & Budgets) Full Time Permanent

LOCATION: CORK, IRELAND ***

The purpose of the Clinical Business Operations (CBO) Associate role is to serve as technical and process expert in exploratory and biopharmaceutics clinical development and the support of the portfolio, clinical trials, and business processes. Key areas of support include: a) study development and execution systems and processes, b) study related contracting and budgeting and c) metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the CBO Associate possesses the business acumen, process knowledge, and influence required to substantively participate in process and quality improvement efforts. The Associate will seek knowledge from internal and external sources and use this information to shape continuous improvement opportunities.

Basic Requirements:

• Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years pharmaceutical industry experience).
• Experience with contract management with vendors and/or clinical sites
• Proficiency with business software packages.
• Ability to travel (varies dependent on responsibilities – if responsibilities require travel up to 10% expected).

Additional Skills/Preferences:

• Knowledge and understanding of: Technical details of clinical study protocols, especially as regards subject inclusion/exclusion criteria, schedules of events and procedures.
• Operational data analysis in excel and various reporting systems
• Experience in clinical development, familiarity with medical terminology, and good clinical practice requirements.
• Exploratory and biopharmaceutics clinical development study processes, clinical site operations
• Experience with Veeva Clinical, Office 365, data visualization software (e.g. Tableau Vault, PowerBI)