Country Approval Specialist - FSP - Poland

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