Regulatory and Submissions Specialist (Clinical Operations Manager)

Clinical Operations Manager (FSP) – Hungary - Permanent opportunity 

Clintec is actively recruiting for a Clinical Operations Manager (FSP) to join our expanding global company in Hungary – this is a Permanent home based opportunity. The successful candidate will work fully assigned to one of our sponsors, a top 5 pharmaceutical company. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description

The Clinical Operations Manager (FSP) will be accountable for the execution and oversight of local operational clinical trial activities in Country. The COM will also be responsible for local regulatory and financial compliance for assigned protocols.

Responsibilities of the Clinical Operations Manager (FSP):

• Take ownership of country and site budgets
• Develop, negotiate and complete of Clinical Trial Research Agreements (CTRA)
• Oversee and track clinical research-related payments
• Perform reconciliation of payments at study close-out
• Track financial forecasting of the operational budget in conjunction with Clinical Research Director
• Execute and oversee the clinical trial country submissions and approvals for assigned protocols
• Develop local language materials including local language Informed Consents and translations
• Manage country deliverables, timelines and results for assigned protocols to meet country commitments
• Collaborate closely with Regional Operations to align country timelines for assigned protocols
• Provide support and oversight to local vendors as applicable
• Oversee and coordinate local processes
• Manage supplies, drug supplies and supplies destruction, importation and exportation requirement, archiving and retention requirements, and insurance process
• Maintain country information in clinical, regulatory, safety and finance systems
  

Essential Criteria:

• Educated to Bachelor's Degree (or comparable) in Business Finance, Administration, Life Science or equivalent Health Care related experience
• 5-7 years’ clinical research experience
• Extensive experience in clinical project management and coordination
• Expertise of core clinical, regulatory and financial systems, tools and metrics
• Extensive knowledge of local regulatory environment and submission and approval processes
• Strong communication and leadership skills
• Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
• The ability to focus on multiple deliverables and protocols simultaneously is essential
• Ability to work effectively also in a remote virtual environment with a wide range of people
• Fluency in English and Hungarian 
• Ability to work office based in Hungary

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.