Job Responsibilities:
Supports country SSU strategy in close collaboration with Study Start-Up Team Lead and Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments
Responsible for accounting and execution of investigator payments in a direct country or extended study group (OPC and satellite countries) in close collaboration with Study Start-Up Manager, Clinical Project Manager and Contracting Specialist in assigned projects
Project controlling & budget management supports financial planning, forecasting and management, analyses, and reports project costs and their drivers
Set-up & validation of investigator contracts in the accounting system for clinical studies
Executes and monitors internal controls
Translates Grant Plans into local Payment Schemes
Prepares and submits country TCF(s)
Updates systems (ACT, Optimus, etc.)
Executes payments, communicates with sites when it comes to payment issues
Tracks and oversees payment status
Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc., as applicable) for assigned projects
Tracks and oversees contract status including the dispatch and return of contracts
Negotiates financial & legal conditions, escalates issues as applicable
Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics)
Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
Implements innovative and efficient processes which are in line with sponsor strategy
Job Requirements:
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; Study start-up and contract negotiation experience preferred
In-depth knowledge of clinical systems, procedures, and corporate standards.
Good negotiating and communication skills with ability to challenge, if applicable.
Effective communication, organizational, and interpersonal skills.
Ability to work independently and to effectively prioritize tasks.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Ability to establish and maintain effective working relationships with coworkers, managers and clients
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
