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 https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
