Irina Sechila

Sponsor dedicated MSD Romania

• Prepare contracts, amendments, and payments
• Negotiate agreements with sites
• Proactively keep the COM informed about contract progress and issues/challenges
• Contact sites to ensure that startup deliverables are met
• Maintain and assure the quality of work generated
• Prioritize effectively and respond to urgent requests within the team or Sponsor lead
• Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and company SOPs, and study-specific procedures
• Perform essential document collection, quality review, scanning, and upload in the client's e-TMF/Veeva Vault system
• Participate in Sponsor, investigator, and team meetings as required.

• Perform essential document collection, quality review, scanning, and upload in the client's e-TMF system dedicated
• Perform feasibility studies
• Create investigator files
• Adapt and prepare the study-specific logs
• Utilize CTMS and company internal data for accurate and efficient investigator recruitment
• Ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
• Support investigators in fulfilling their obligations regarding submission according to local regulatory and IRB/IEC requirements
• Perform Study Tracking to ensure that the study files are current, accurate, and complete
• Assist with resolution of investigative site/data queries
• Liaise with internal and external customers to meet project-specific goals
• Act as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals
• Support CRA/Clinical Team Lead in the management of investigational sites to ensure compliance with the trial protocol, ICH-GCP, and applicable regulation
• Provide quality review of the informed consent form, ICF checklist, and prepare country-specific ICFs
• Support CRA/Clinical Team Lead in the management of clinical budget and evaluation of study processes

• Process accounts and incoming payments in compliance with financial policies and procedures
• Reconcile account discrepancies in a timely manner (Tina, Om Computer)
• Reconcile all payments and reversals that were missed in the original posting process
• Answer client, customer, and supplier questions regarding accounts and any discrepancies
• Resolve outstanding issues
• Generate financial statements and send them to outstanding customers
• Make daily collection calls
• Maintain an accurate aging report Identify and implement opportunities for process standardizations and improvement