20 ago - Abano Terme
Fidia Farmaceutici
Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D;, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Skin Care, Eye Care, Health&Wellness; Care, Specialty Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well with wholly own subsidiaries. With the aim of strengthening the Corporate Clinical Development Team, we are recruiting a **Corporate Clinical Development Specialist** **Main Responsibilities**: - You will ensure that sponsored clinical studies are initiated and completed in compliance with applicable legislation, guidelines and company SOPs.
- You will create and/or review study documents.
- You will contribute to budget planning and control by providing cost estimation, forecast & budget revision and reconciliation.
- You will conduct CRO and/or vendor selection, ensuring oversight of delegated activities.
- You will manage investigational sites (study feasibility, site selection and evaluation, contract and budget negotiation, oversight).
- You will prepare and/or review of scientific papers.
- You will act as primary contact for the study and provide support to members of the multidisciplinary project team, internally and externally.
- You will participate and coordinate relevant clinical studies related meetings (such as Bid Defense Meeting, Scientific Advice, Steering Committee). **Requirements**:
- Bachelor Degree and, preferably, Master Degree in Life Science disciplines.
- 3 years of experience in managing clinical studies and/or clinical development programs, in a pharmaceutical company.
- Experience in CRO selection and experienced in bid defence meetings, budget control/negotiations, project management and CRO oversight management.
- Knowledge of good clinical practice (GCP) and UNI EN ISO 14155:2020.
- Previous experience in international multicentre clinical trials (Phase I-III) is preferable.
- Excellent organizational and time-management skills, able to meet deadlines.
- Good communication and presentation skills, both verbal and written
- Ability to work cross functionally and as part of a team.
- Fluent in both spoken and written English. **Our offer**: - Open ended contract.
- “B” grading of Chemical Pharmaceutical National Collective Agreement.
- Salary between € 42.000 and € 53.000.
- Collective Premio and company Welfare. **Fidia benefits**: In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.
- Fidia Farmaceutici promotes parity and inclusion in all its actions._
- All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department._
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