Clinical Operations Manager (SSU)
- Experience Level
- Experienced (non-manager)
Clinical Operations Manager (SSU) – Hungary- Permanent Contract - Home/Office based opportunity.
Do you want to be part of an award-winning global clinical research organisation who is positively working towards improving the health and lives of millions?
Clintec is actively recruiting for a Clinical Operations Manager (FSP) to join our expanding global company in Hungary – this is a Permanent Office 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.
The Clinical Operations Manager (FSP) will be accountable for the execution and oversight of local operational clinical trial activities in Hungary. The COM will also be responsible for local regulatory and financial compliance for assigned protocols. Responsibilities include:
- 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
To be successful in the role of Clinical Operations Manager (FSP) candidates should have:
- 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 a mix of home/office based in Bugapest
WHAT’S IN IT FOR YOU?
At Clintec, we understand that our people are our biggest asset and we value the hard work and dedication of all our employees.
By joining the Clintec team you can expect:
- A competitive salary, car allowance, 28 days annual leave, home-working, private health care and a friendly and social working environment!
- Opportunity to work with global pharmaceutical leaders in roles fully dedicated to a single sponsor
- Opportunity to work on ground-breaking, challenging studies in various therapeutic areas
- Real career development opportunities within a friendly and social team where you can truly shine and make an impact
Click Apply Now to send your CV of email us directly on email@example.com for more information!
Clintec (an IQVIA company), established for 22 years, is an award-winning, full-service global clinical research organisation with our HQ office based in Scotland, UK. We support key product development and manage clinical trials in over 50 countries worldwide, across all major therapeutic areas, with expertise in Oncology and Rare Disease studies. We differ from other players in the clinical research industry as we combine the agility and flexibility typical of smaller CROs with the global coverage and management associated with large CROs.
Find out more by visiting www.clintec.com