Country Approval Specialist - FSP - Poland

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. What You’ll Do: · Work directly with assigned sites on all site related essential document collection and review. · Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall SSU metrics and deliver processes. · Ensure standards are applied to the SSU processes across projects. · Promptly recognize and improve potential site activation delays and escalate to appropriate team members. · Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned. · Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team. · Review and provide feedback to management on site performance metrics. · Ensure accuracy and completeness of the eTMF for assigned sites during start Education and Experience Requirements: · BSc degree or international equivalent · 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor. · Ability to explain data to facilitate decision making processes to be data driven. · Knowledge and understanding of clinical study protocols and essential documents · Strong organizational skills, decision making, communication and negotiation skills · Proficient in Microsoft Excel, Word, and PowerPoint Knowledge, Skills and Abilities: • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the ability to learn appropriate software • Good English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, under direction, as required • Basic organizational and planning skills • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves