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Aggiornato il 03/10/2022
- Senior Clinical Project Manager - Swiss CRO
- Medical Devices and Pharma
Il nostro cliente
Our client is an international company of skilled professionals from the medical device and pharmaceutical industry, from clinical research and the regulatory field. Our client is a dynamic and proactive group that offers the medical device and pharmaceutical industry regulatory support, digital solutions and full-service CRO assistance focused on innovation, continuous improvement, scalability and customization.
Tasks and responsibilities:
- Leads, motivates, sets objectives, and manages performance of the assigned resources to assure completion of organizational goals, in a diverse and inclusive environment
- Oversee the clinical projects of assigned resources including trial management, timelines, budgets, and vendors, including the review and preparation of specific budget amendment.
- Identify training needs to foster high level of performance, support career development.
- Collaborate in the preparation of new quotations for clients and interaction during the negotiation phase.
- Ensure the execution of the clinical trials entrusted to the Sponsor in compliance with the deadlines, guaranteeing the achievement of the qualitative/quantitative objectives agreed with the Sponsor.
- Coordinate and drive all the clinical services involved in the project (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) during the entire life cycle of the study and as per applicable SOPs, budget and timelines agreed internally and with Sponsor and applicable regulations.
- Act as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timelines).
- Lead the periodical Sponsor meeting/Call. Finalize and approve the related minutes.
- Acquire the study documentation produced by the Sponsors and collaborate and coordinate the study core documents preparation required for the submission and application for approval of the study.
- Preparation and maintenance of Study Manuals.
- Set-up and maintenance of the Trial Master File.
- Set-up and maintenance of the Investigator Study File and coordination of delivery to experimental centers involved in the study.
- Lead the monitoring activities as per monitoring plan, budget and agreement with Sponsor.
- Keep aligned, with expected metric, the timelines related to the Monitoring visit report delivery.
- Provide specific study training (Protocol, CRF, etc.) for the 1MED Study team and, where required, for the hospital staff involved.
- Participation in Investigator Meetings and/or teleconferences related to the assigned study and drafting of the minute.
- Manage the findings found during an audit/inspection of a clinical trial and ensure that the necessary corrective actions are implemented.
- Ensure that serious adverse events are managed in accordance with the protocol and applicable legislation.
- Implement and maintain the necessary procedures for the management of clinical trials in accordance with GCP/ISO/MDD/MDR and all applicable regulation.
- Report major violations of protocol, GCP and SOPs to the Head of Quality Assurance and Top Management.
- Escalate to the direct superior all deviation from the qualitative/quantitative objectives, deadlines and budgets.
Il candidato prescelto
Education: Bachelor / Master of Science / Master's Degree in scientific disciplines or equivalent experience (at least 10 years) in Clinical trial- related activities
Experience: At least 3 years of professional experience in the role of Clinical Trial Manager/Clinical Project Manager
- Excellent organization and management skills.
- Excellent client-facing and internal communication skills including negotiation aspects.
- Results oriented.
- Knowledge of clinical trial design and development.
- Good knowledge of English language (written and spoken).
- Knowledge of other languages such as German and French is appreciated.
Cosa comprende l'offerta
Ottima opportunità di carriera.
- Healthcare & Life Sciences
- Clinical Operations
- Healthcare / Pharmaceutical
- Tipo di contratto
- Nome del consulente
- Leonardo Giovanditti
- Numero dell´offerta