Inés Agnieszka Duleba

• Leadership of the Start up phase, going beyond contracts and regulatory approvals ensuring other deliverables arrive on time for Site Ready
• Coordination and oversight of local processes such as medication and other supplies management, import and export requirements, filing requirements
• Ownership of country and site budgets
• Development, negotiation and completion of Clinical Trial Research Agreements (CTRA)
• Oversee and track clinical research-related payments
• Payment reconciliation at study close-out
• Financial forecasting in conjunction with Sr.COM /other role
• Finance CTCs Functional Manager
• Vendor owner leading the RFI and RFP with procurement department exploring other vendors
• Development of local SOPs and Supporting Documents
• SME of CTRA process, collaboration across different departments, local contracts templates development
• COM POC of Hospital Germans Trias y Pujol

• Supervision of submissions to CEIm and AEMPs, interacting with the Competent Authorities
• Management of country and site budgets, supervision and coordination of payments to sites and suppliers
• CTRA SME
• Development and negotiation of budgets and contracts
• Development of study specific materials, such as ICFs
• Management and coordination of local processes such as medication management and other supplies, import and export requirements, local electronic and paper file requirements, document retention
• Contribution to the development of local SOPs.

• Perform and coordinate all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget payment schedule terms and conditions and ancillary documents, with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study
• Review CRO and/or client site contract templates and budgets for compliance with local legislation and practices
• Adapt the site contract template to client and investigational site requirements in collaboration with key stakeholders to include the project team and the PPD legal team
• Facilitate effective budget negotiation with site personnel in collaboration with key stakeholders
• Perform and coordinate all amendments to site contracts and financial agreements with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study
• Serve as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study
• Assume responsibility for any ongoing contract or budget amendments
• Worked with investigational sites to negotiate budget for Oncology, Respiratory, Endocrine/Metabolic, Transplants, Nervous System/Sense Organs and Dermatology studies.

• Involved in several different projects simultaneously with different Sponsors in different therapeutic areas as Oncology, Infectious Diseases, Digestive System or Neurology
• Maintenance of eTMF and CTMS systems on an ongoing basis performing File Reviews biannually to keep them audit ready
• Quality Control of documents before uploading them into eTMF according to ICH-GCP quality standards
• Creation of different guidelines of File Review, eTMF maintenance and Amendment submission documents
• Set Up of essential documents needed for SIV preparation in eTMF
• Trainer of Junior PAs in different areas such as Site Initiation Visit File Preparation and File Review
• Mentor of Junior PAs, helping them to adapt themselves to the company and their procedures and systems.