• Oversee regulatory and ethics submissions for assigned projects/countries/sites, including completion of submissions or notifications as required.• Prepare, review, and negotiate Clinical Trial Agreements, budgets, and ancillary agreements with Study Sites.• Establish and agree on project plans and timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.• Track and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) releases, ensuring alignment with project timelines.

• Clinical Trials Management: Oversee site regulatory documents, maintain relationships with sites, and manage data archiving for Phase IIIb-IV (IIS) and CSS (NIS) sponsored trials.• Medical Affairs Support: Assist in preparing documents and presentations for hospital meetings, advisory boards, and expert panels.• Medical Information: Handle clinical queries from healthcare professionals and train sales representatives on company products.