For one of our Clients in Breda (NL) we are looking for a Clinical Operations Contracts & Budgets associate for the reinforcement of the team.
Job description
Provide clinical site contracting services to clinical study teams to support study start up and conduct activities.
Responsibilities
Job description
Provide clinical site contracting services to clinical study teams to support study start up and conduct activities.
Responsibilities
- Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving).
- Support site-related questions regarding invoice preparation with respect to submission of invoices in the Payment System (eGPS)
- Support resolution of contract issues
- Support contracting with local GSO vendors
- Maintain contract tracking in appropriate systems
- Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
- Ensure payments are made in accordance with contracts
- Maintain payment data tracking in appropriate systems
- Responsible for providing information for entry into systems
- Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution
- Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final Schedule A for addition to contract
- Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance
- Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems (eFinity, MyBuy, SAP).
- Support Clinical Pricing & Payments Group in setting up sites for eGPS or legacy systems.
- Track contract progression using appropriate systems
- Amend and terminate contracts as necessary throughout lifecycle of study
- Store and archive contracts and budgets in appropriate systems
- Maintain payment records and provide assistance with audit review records
- Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2.
- Responsible and/or point-of-contact at vendor level for the contracting process for locally outsourced studies
- Responsible for the Clinical Trials Insurance process
- Participate in appropriate site/legal meetings as required to resolve contract issues
- Participate in appropriate site/finance meetings as required to resolve payment issues
- Maintain party information and contract activation in Contract Generation System
- Approve or reject clinical invoices
- Process and track Confidential Disclosure Agreements as appropriate
- Manage contracting process with Clinical Trial Related Consulting Agreements
- Manage all study-related Site payments not managed by Clinical Pricing & Payments Group
- Finalized contracts and budgets
- Executed contracts
- Status reporting and updates
- Payment execution
Requirements
- Master’s degree OR Bachelor’s degree
- A first experience in Legal, Negotiation, Finance and/or Clinical Research
- Knowledge of local contracting processes in applicable countries
- Knowledge of local payment processes in applicable countries
- Attention to detail
- Negotiation skills
- Organizational Skills
- Relationship management
- Time management & prioritization
- Flexibility
- Written and oral communication skills in English and Dutch
- Good working knowledge of common software packages (e.g. Office 365 esp. Excel, SAP)
- Data analysis and presentation skills
- Problem solver
- Team work