About this role
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.