Category: Scientific & Clinical
40.00 - 45.00 Per Hour
Supports successful clinical trials by negotiating budgets and contract payment terms with sites and investigators in accordance with all relevant regulations and policies.
Clinical Finance & Operations of North America Clinical Operations. Has extensive interaction with clinical site personnel, including Principal Investigators, Study Coordinators, and Contract Administrators, at trial startup and as a key contact during trial execution. Is a contributing member of study teams. Interacts frequently with Legal department. Coordinates extensively with ClinicalFinance & Operations Sr. Associates.
Essential Functions – Project Support:
- Reviews clinical trial protocols and develops investigator cost per patient budgets and site contracts for North America (US and Canada) Clinical Operations.
- Coordinates with Trial Managers to plan site contract negotiations in conjunction with trial startup targets.
- Directly negotiates contracts with sites in accordance with established policies.
- Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines. Escalates issues for approval as required.
- Ensures compliance with the application and communication of all client policies and procedures.
- Compiles key study information for tracking and trending and reports to Manager of Clinical Finance and Operations, and Trial Managers.
- Independently researches complex legal and business issues in support of budget determination and negotiation, makes recommendations.
- May support the maintenance of guidelines, training programs, policies and procedures related to Clinical Trial contracts and budgets
- Provides project direction to Clinical Finance and Operations Sr. Associates
- Serves a key role in establishing and maintaining effective site relations. PROJECT SUPPORT: Utilizes current systems to support budget development and reports, draws conclusions, and may make recommendations to the Trial Managers and Finance Managers in relation to budgets. Participates in budget challenge meetings.
- Accountable for compliance and quality of CATS reporting.
- Active membership to local/global project teams.
- Assists with ensuring that quality of performance is in accordance with departmental expectations for function.
- Attends relevant team and department meetings, forums, conferences and scientific meetings, as necessary.
- Identifies, leads, develops, supports and communicates functional, departmental or organizational initiatives.
- Participates in cross-functional teams locally/globally to assure timely attainment of project milestones.
- Provides support for the implementation of continuous improvement processes for role and/or function.
- Responsible for conducting oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to maintain focus for specific project activities within CTM priorities.