Contracts & Budgets Associate – Centre of Excellence
- Establish, maintain, and archive compound-related files and trial-related files as required by procedures.
- In IMPACT, create and maintain the clinical plan and compound information.
- Assist with the trial budget, PO, and invoice planning, forecasting, and tracking.
- Support efforts in establishing consulting agreements (vendors and investigators).
- 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.
- When necessary, assists study teams with issue escalation and dispute resolution.
Systems and Processes Support:
- Create and maintain collaboration sites at process, compound, or trial levels for the organization.
- Proactively establish and ensure accuracy and completeness of information in Veeva Vault Clinical, IMPACT, Planisware, and other critical business systems, producing reports as needed.
- Assists in the development and maintenance of business processes.
- Represents Clinical Business Operations in the evaluation and contracting of potential vendors.
- Assist in the upkeep of study archetype templates
- Assist the organization’s knowledge management and archival activities. • Provide assistance with portfolio delivery tools.
- Assist with Training curricula assignments and system updates.
- Take the lead on Privacy / GDPR (EU) / other compliance initiatives.
Metrics, Reporting, and Systems Maintenance:
- Identify, evaluate, and interrelate data to inform business processes and enable organizational decisions, investigate issues, and identify trends and areas for improvement.
- Create and run system reports for metrics as well as proactively address gaps in required fields
- As needed, generate organizational metrics/measures, milestone reports, staff capacity reports, and other reports (e.g. bottleneck reports)
- Support capacity planning and accurate reporting of project time through coordination of CATS entries.
- Encourage the use of systems and databases (for example Trackwise deviation or change mgmt systems).
- Work on evaluating vendor performance and sharing TPO performance metrics with company management.
- Manage and update organizational charts and job descriptions
- Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience
- Excellent self-management, analytical, and organizational abilities.
- Contract management experience with vendors and/or clinical sites
- Proven problem-solving abilities.
- The ability to prioritize and manage a large number of activities.
- Knowledge of business software packages.
- Strong communication skills and willingness to collaborate globally.