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Senior Study Start-Up Specialist

Job Field:
CRM (Clinical Research Management) Jobs
Clinical Operations Jobs, Feasibility Manager Jobs
Italy All
Contract Type:
Salary Description:
Competitive Salary Offered
Job Ref:

Senior Study Start-Up Specialist​ - Rome, Italy – Permanent Contract

Clintec is actively recruiting for a Senior Study Start Up Specialist (COM) to join our expanding global company in Italy. This is a full-time and permanent contract, working office based in Rome. 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 Senior Study Start Up Specialist (COM) will be accountable for the execution and oversight of local operational clinical trial activities in Italy. The COM will also be responsible for local regulatory and financial compliance for assigned protocols.

Responsibilities of the Senior Study Start-Up Specialist:
- 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 both English and Italian languages
- Ability to work office based in Rome, Italy

Closing Date:

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