Clinical Trial Assistant
6 mesi fa
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.
ClinChoice, is searching for a Clinical Trial Assistant to join an international pharmaceutical company, with a focus on Respiratory, Paediatrics, Rare Disease and Special Care. This is an office based, full-time opportunity in Verona, Italy.
**Main Job Tasks and Responsibilities**:
- Prepares/assembles study documentation, including submission package to Regulatory Authorities and Ethics Committees, study documents prepared through EDMS, reviews English texts and translations, and is in charge of formatting study documents, such as study protocols, clinical study reports, etc.
- Responsible for electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness, through ongoing quality checks and metrics, oversight of CRO filing activities in the eTMF.
- Responsible for eTMF and paper TMF reconciliation after study completion.
- Participates in the completion and review of Requests for Proposals sent to CROs in collaboration with the Clinical Project Manager.
- Follows the CRO Awarding Process and handles the invoice process.
- Provides input for budget development at Forecast, and Preclosing; checks monthly costs invoiced to the Sponsor based on planned study activities vs actual through our dedicated tool and ensures that invoices received are as expected; manages the Investigator Fees reconciliation and supports the Clinical Project Manager in all activities related to budget operations.
- Organizes and participates in Kick Off Meetings, Study Design Meetings, and phone conferences with the CROs for continuous updates on clinical studies. May participate, if required, in the Investigator's Meetings and other study-specific meetings.
- Assists with CRO oversight, and ensures that the trial complies with SOPs and all necessary quality standards.
- Collaborates with the Clinical Project Manager with corrective and preventive actions, in case of deviations and following audits.
- Reviews SOPs, if required.
- Assists the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier.
**Education and Experience**:
- Bachelor's degree
- Experience in clinical research or the healthcare-related industry, including as a Clinical Trial Assistant
- Working knowledge of international regulatory and ICH-GCP guidelines
- Experience managing study budgets, study documentation and TMFs is essential
- Experience with early-phase clinical trials (beneficial)
- Experience working as part of a large team with proven ability to make an active contribution to the team's performance and teamwork
**Specific Role Requirements and Skills**:
- Good documentation practices
- Self-motivated and displays initiative
- Able to communicate clearly and accurately in both written and spoken English and Italian
- Effectively collaborates with team members
- Proven organizational skills demonstrated by the ability to understand and prioritize instructions and deliver against commitments on time
- Attention to detail
**Our Benefits**:
- Excellent work-life balance
- Dedicated Line Manager
- Full performance and development process with end of year reviews
- Career opportunities within in ClinChoice, locally and globally
- Employee satisfaction survey - your feedback is important for continuous improvement
**The Application Process**:
**Who will you be working for?**
**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities.
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