Contracts & Budgets Associate / Senior Associate 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. 

• Create and maintain clinical plan and compound information in IMPACT.
• Given a final protocol, lead the authoring of CT Registry entries at beginning of a trial.
• Obtain or prepare relevant documentation necessary for a clinical trial based on GCP or Local regulations for Site Activation, Maintenance and Close-out (e.g. New Trial Statements for insurance certificates, copyright permissions and document translations, Clinical Trial Applications)
• Assist in the planning, forecasting, and tracking of trial budgets, POs and invoices.
• Support efforts in establishing consulting agreements (vendors and investigators).
• Understand FRAP and consult with teams regarding FRAP compliance.
• Ensure Legal, Procurement and Financial processes are completed for assigned TPOs.
• Support study teams with sourcing activities by:
  • Gaining agreement on sourcing timelines and expectations with the team.
  • Liaising with Procurement to obtain competitive study bids.
  • Preparing Study Work Orders (SWOs) and contracts with Procurement and Legal.

• Proactively establish and ensure accuracy and completeness of information in Veeva Vault Clinical, IMPACT, Planisware and other critical business systems, producing reports as needed. 
• Help maintain study archetype templates
• Provide leadership & support for Training curricula assignment and system updates.

• Identify, evaluate, and interrelate data using means to advise business processes and enable organization decisions, investigate issues, and identify trends and improvement areas. Create and run system reports for metrics as well as proactively address gaps in required fields. Generate organizational metrics/measures, milestone reports, staff capacity reports, and other reports as needed (e.g. bottleneck reports)
• Support capacity planning and accurate reporting of project time through coordination of CATS entries.
• Support use of systems and databases (e.g.: Trackwise deviation or change management systems).

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

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.
  • Experience with Veeva Clinical, Office 365, data visualization software (e.g. Tableau Vault, PowerBI)