Preparing for MBA application in New Bulgarian University to further develop business analytics skills.

• Management and oversight of negotiation of clinical trial agreements with investigative sites worldwide • Point of escalation for contractual and budgetary requests coming from local contract negotiators • Accurate forecast of contract execution timelines in support of timely site startup for the conduct of clinical trials • Communicate and explain legal/ budgetary issues to internal and external parties per department guidelines and ensure country-specific laws and regulations are followed. • Review and evaluate client requested contract changes and based upon department guidelines escalates deviations as appropriate. • Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts. • Interact and collaborate with other functional areas, including other study-start up colleagues and CRAs • Serve as the study-specific point of contact with the ICON project team and sponsor’s legal team on contract and budget matters. • On a project basis, set the parameters for and lead the progress of the contracts process across a region of countries, coordinating the work of Contracts Associates. • Serve as point of escalation for sites that are unresponsive or slow to negotiate • Monitor and assist with the delivery of all study CTAs to achieve outputs according to delivery timelines and standards detailed with Sponsor •Responsible for developing of the Governance Plan inline with Client specifications • Provide substantive guidance, monitoring, and support regarding CTA deliverables, including undertaking activities identified in the Governance Plan

• Management of negotiation of clinical trial agreements with investigative sites. • Accurate forecast of contract execution timelines in support of timely site startup for the conduct of clinical trials • Communicate and explain legal/ budgetary issues to internal and external parties per department guidelines and ensure country-specific laws and regulations are followed. • Review and evaluate client requested contract changes and based upon department guidelines escalates deviations as appropriate. • Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts. • Interact and collaborate with other functional areas, including other study-start up colleagues and CRAs • Serve as the study-specific point of contact with the ICON project team and sponsor’s legal team on contract and budget matters. • On a project basis, set the parameters for and lead the progress of the contracts process across a region of countries, coordinating the work of Contracts Associates. • Serve as point of escalation for sites that are unresponsive or slow to negotiate • Monitor and assist with the delivery of all study CTAs to achieve outputs according to delivery timelines and standards detailed with Sponsor •Responsible for developing of the Governance Plan inline with Client specifications • Provide substantive guidance, monitoring, and support regarding CTA deliverables, including undertaking activities identified in the Governance Plan

• Negotiation and on-going management of clinical trial agreements with investigative sites.• Accurate forecast of contract execution timelines in support of timely site startup for the conduct of clinical trials• Communicate and explain legal/ budgetary issues to internal and external parties per department guidelines and ensure country-specific laws and regulations are followed.• Review and evaluate client requested contract changes and based upon department guidelines escalates deviations as appropriate.• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.• Interact and collaborate with other functional areas, including other study-start up colleagues and CRAs• Serve as the study-specific point of contact with the PRA project team and sponsor’s legal team on contract and budget matters.• On a project basis, set the parameters for and lead the progress of the contracts process across a region of countries, coordinating the work of Contracts Associates.• Serve as point of escalation for sites that are unresponsive or slow to negotiate• Monitor and assist with the delivery of all study CTAs to achieve outputs according to delivery timelines and standards detailed with Sponsor• Provide substantive guidance, monitoring, and support regarding CTA deliverables, including undertaking activities identified in the Governance Plan

• Negotiation and on-going management of clinical trial agreements with investigative sites.• Accurate forecast of contract execution timelines in support of timely site startup for the conduct of clinical trials• Communicate and explain legal/ budgetary issues to internal and external parties per department guidelines and ensure country-specific laws and regulations are followed.• Review and evaluate client requested contract changes and based upon department guidelines escalates deviations as appropriate.• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.• Interact and collaborate with other functional areas, including other study-start up colleagues and CRAs

• Agree and negotiate contract template with project leader and sponsor• Gather relevant study information and communicate contract strategy, turnaround timelines and budget information/updates with the study team• Resolves negotiation issues that have arisen at the clinical site• Management of CSA activities and coordinate interaction between clinical team, project management team and sponsor to ensure that the CSA start-up deliverables are met• Early recognition of areas of potential problems• Define solution strategy• Participate in client, investigator and team meetings• Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs and study specific procedures