Porta Futuro Lazio
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Offerta di lavoro
SENIOR STUDY MANAGER (rif. offerta: 434973.14)
Azienda
viale Amelia , 70 - 00181 ROMA
Caratteristiche
Descrizione: SENIOR STUDY MANAGER
Job Description:
Angelini Pharma is looking for a brilliant candidate to fill the position as Senior Study manager in our Global Medical Department.
Responsibilities
The study manager will participate to Phase I-IV Clinical studies activities on OTC drugs, medical devices, Food supplements and Cosmetics to ensure the high quality and on-time delivery of all clinical data in compliance with the clinical development plan, good clinical practices (GCP), and internal SOP.
The responsabilities will include:
-Design clinical trial protocols, oversight and management of the studies from start up to study closure
-Serve as the accountable for the overall delivery of the clinical trial, analyze and interpret the results as a subject matter expert and assure that results meet the planned timelines, the highest standards of quality and ethical conduct.
-Manage multiple vendors and CRO service providers according to the project timelines and the study budget
Requirements
-Academic degree in relevant life sciences
-Minimum 2 year of experience in clinical trial management experience in pharmaceutical, biotech or CRO or minimum 5 years of experience working in a scientific or medical institution
-Good knowledge of spoken and written English
-Understanding of GCP and ICH guidelines
-Ability to work well within a challenging environment, balance priorities, and independently handle multiple tasks through good planning, project management and organization skills.
-Ability to critically analyse information, identify strengths and weaknesses of approaches and proactively develop remedial actions to mitigate risks.
-Effective ability to prioritize tasks and deliver on deadlines, with high performance standards
-Proven computer skills (MS Office, PowerPoint) and software experience (CTMS, eTMF)
-Digital skills
Tipologia di contratto: Contratto di lavoro a tempo indeterminato
Tipo orario: Fulltime
Figure professionali: Tecnici sanitari di laboratorio biomedico (0 posti)
Requisiti del candidato
- Titoli di studio richiesti:
- Scienze biologiche (Corso di laurea) [facoltativo]
- Medicina e chirurgia (Corso di laurea) [facoltativo]
- Altri titoli o attestati richiesti: Esperienza nell'utilizzo dei programmi MS Office, PowerPoint, CTMS, e TMF, Capacità di organizzare il lavoro valutando le priorità, Capacità di valutazione delle informazioni ed identificarne punti di forza e debolezza, Comprensione delle linee guida GCP e ICH