• review and negotiate clinical site investigator contracts and budgets• lease with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related document• coordinate preparation of contractual documents and correspondence• function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution)

• Prepare, review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals• Prepare, review and approve country related submission packages• Prepare, review and approve site level critical documents for IP release• Develop and finalize Master and Country Specific SIS/ ICFs.• Perform feasibility, site identification, etc. as required• Site contract and amendments negotiation• Review and translate Drug Labels

• Implement and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and GCP guidelines (site visits to assess the qualification of investigative sites, train site personnel on proper conduct of studies, review data and ensure accuracy of the data collected terminate the studies)• Work closely with other team members to ensure timely resolution of project issues and provides regular clinical status information to project management• Perform investigative site file reconciliation for site-related essential and non-essential documents according to appropriate local regulatory requirements, project Standard Operating Procedures and sponsor requirements

• Study site management - site selection, initiation, monitoring and close-out visits in accordance with scope of work and GCP• Evaluate the quality and integrity of data, assuring proper conduct of the protocol and adherence to applicable regulations• Maintain appropriate documentation regarding site management, monitoring, findings and action plans by submitting visit reports on regular basis

• Coordinate clinical trials in dedicated sites in Poland• Establish communication with sites to manage project expectations and issues• Prepare recruitment and retention strategy for patients in certain study sites

• Submission of Study documents to Ethics Committee and Competent Authorities• Preparation of study documents for Investigational Product release and site initiation • Coordination of investigator’s and site’s payments