Country Approval Specialist - FSP - Italy
On-siteMilan, Lombardy, Italy
Milan, Lombardy, ItalyOn-siteFull TimeLarge
Full TimeLarge
Job Summary
Manage site start-up approvals by reviewing essential documents including ICFs, FDFs, and CVs to ensure prompt activation and study timelines. Partner with internal Study Startup teams, CROs, and Clinical Operations to resolve escalated issues and improve overall SSU metrics. Track all communications with assigned sites to maintain accuracy in the eTMF and review site performance metrics for management. Work directly with sites to collect required documentation and recognize potential activation delays immediately.
Required Qualifications
- 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
Desired Qualifications
- 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
- Demonstrated ability to work across functions, regions and cultures
- 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
- 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
- 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
- Ability to work in a global ecosystem (internal and external) with a high degree of complexity
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