Financial COM

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

Description of Roles and Responsibilities:

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations Sponsor policies and procedures quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD the person is responsible for budget/finance aspects for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Hybrid role requiring office visits at least 2 x a week.

Responsibilities include but are not limited to:

Ownership of country and site budgets. Development negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments.
Payment reconciliation at study close-out. Oversees FCPA DPS/OFAC and maintenance of financial systems.
Financial forecasting in conjunction with SCOM /CRDs other roles.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents and translations.
Interacts with IRB/IEC and Regulatory Authority for assigned protocols. Manages country deliverables timelines and results for assigned protocols to meet country commitments.
Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees CTCs as applicable. Coordinates and liaises with CRM CTC CRA (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions budgets CTRAs and local milestones.
Collaborates closely with Headquarter to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable. Oversees and coordinates local processes clinical and ancillary supplies management importing and exporting requirements supplies destruction local electronic/hard copy filing archiving and retention requirements and insurance process management.
Enters and updates country information in clinical and finance systems. Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Required to in/directly influence investigators external partners and country operations to adheres to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations finance regulatory affairs pharmacovigilance legal and regional operations HQ functional areas and externally with vendors and sites IRB/IECs and Regulatory Authorities in submission and approval related interactions.
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Contribute or lead initiatives and projects adding value to the business Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME) sharing best practices making recommendations for continuous improvement and providing training as appropriate/required.
Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Experience Required:

5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

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

Description of Roles and Responsibilities:This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations Sponsor policies and procedures quality standards and adverse event reporting requirements internally and externall...

Hybrid role requiring office visits at least 2 x a week.

Responsibilities include but are not limited to:

Ownership of country and site budgets. Development negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments.
Payment reconciliation at study close-out. Oversees FCPA DPS/OFAC and maintenance of financial systems.
Financial forecasting in conjunction with SCOM /CRDs other roles.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents and translations.
Interacts with IRB/IEC and Regulatory Authority for assigned protocols. Manages country deliverables timelines and results for assigned protocols to meet country commitments.
Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees CTCs as applicable. Coordinates and liaises with CRM CTC CRA (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions budgets CTRAs and local milestones.
Collaborates closely with Headquarter to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable. Oversees and coordinates local processes clinical and ancillary supplies management importing and exporting requirements supplies destruction local electronic/hard copy filing archiving and retention requirements and insurance process management.
Enters and updates country information in clinical and finance systems. Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Required to in/directly influence investigators external partners and country operations to adheres to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations finance regulatory affairs pharmacovigilance legal and regional operations HQ functional areas and externally with vendors and sites IRB/IECs and Regulatory Authorities in submission and approval related interactions.
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Contribute or lead initiatives and projects adding value to the business Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME) sharing best practices making recommendations for continuous improvement and providing training as appropriate/required.
Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Experience Required:

5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Key Skills

Financial Services
Financial Models
Account Management
General Ledger Accounts
ERP
Payroll
External Auditors
Customer Relationships
Credit Card
Financial Statements
Business Units
Annual Budget
Income
New Clients
Financial Management

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About Company

IQVIA

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

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