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Study Start-Up Specialist (SSU)

Job Field:
CRM (Clinical Research Management) Jobs
Clinical Trial/Study Manager Jobs, CRM Jobs, Senior Management Jobs
Italy All
Contract Type:
Salary Description:
Job Ref:

Senior Study Start Up Specialist / Submissions Specialist – Rome, Italy

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

Company Information:

Clintec is a UK-based, dynamic and privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over a decade. At Clintec, we pride ourselves on providing high quality, flexible and professional services and solutions to our clients. Clintec has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular disease, psychiatry, infectious diseases, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnership with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a market competitive salary and rewards and benefits package.

Closing Date:

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