Country Approval Specialist - Fsp - Italy

**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: **_OBJECTIVES/PURPOSE_** * Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved. * Support sites and study teams to achieve rapid site start up. **_ACCOUNTABILITIES_** * 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. * Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc * 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 up **_DIMENSIONS AND ASPECTS_** **Technical/Functional (Line) Expertise** * Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.) * Understanding of Clinical Trial Agreements, budgeting and fair market value principals * Knowledge or FDA and ICH-GCP guidelines for conducting clinical research **Leadership** * Demonstrated ability to work across functions, regions and cultures * The ability to inspire, motivate and drive results * Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing * Proven skills as an effective team player who can engender credibility and confidence within and outside the company * Ability to distil complex issues and ideas down to simple comprehensible terms * Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization **Decision-making and Autonomy** * Broad decision-making responsibilities: * Ability to make decisions * Accountable for decision making for designated tasks * Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions * Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution  **Interaction** * Effectively navigates the changing external and internal environment * Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner * Takes the initiative and proactively resolves challenges with internal and external team members. **Complexity** * Ability to work in a global ecosystem (internal and external) with a high degree of complexity **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** * BS 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.