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.
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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.
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Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall SSU metrics and deliver processes.
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Ensure standards are applied to the SSU processes across projects.
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Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
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Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
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Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
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Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
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Review and provide feedback to management on site performance metrics.
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Ensure accuracy and completeness of the eTMF for assigned sites during start up
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
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Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
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Understanding of Clinical Trial Agreements, budgeting and fair market value principals
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Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
Leadership
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Demonstrated ability to work across functions, regions and cultures
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The ability to inspire, motivate and drive results
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Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
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Proven skills as an effective team player who can engender credibility and confidence within and outside the company
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Ability to distil complex issues and ideas down to simple comprehensible terms
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Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Decision-making and Autonomy
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Broad decision-making responsibilities:
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Ability to make decisions
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Accountable for decision making for designated tasks
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Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
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Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
Interaction
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Effectively navigates the changing external and internal environment
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Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
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Takes the initiative and proactively resolves challenges with internal and external team members.
Complexity
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Ability to work in a global ecosystem (internal and external) with a high degree of complexity
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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BS degree or international equivalent
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2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
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Ability to explain data to facilitate decision making processes to be data driven.
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Knowledge and understanding of clinical study protocols and essential documents
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Strong organizational skills, decision making, communication and negotiation skills
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Proficient in Microsoft Excel, Word, and PowerPoint.
