Clinical Operations Associate Contracts &

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

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