- Salva l´offerta
Pubblicato il 02/03/2022
- Realtà in forte espansione
- Opportunità di crescita e sviluppo professionale
Il nostro cliente
Our client is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access.
Ruolo
- Define and drive study timelines and milestones
- Coordinate the development of project specifications in collaboration with clinical and regulatory teams and ensure appropriate quality control of deliverables
- Contribute to the development of regulatory documents, responses to Health Authorities, ECandDSMB questions
- Plan, organize and lead Investigator meetingsand CRA trainings& review related material
- Oversee monitoring activities and conduct co-monitoring visits (if applicable) to ensure data quality
- Providestudyspecificdirectiontostudy team members
- Address enrolment and retention issues, identify and implement actions to keep study on track*Ensure proper study documentation is maintained and archived in the TMF
- Resolve issues in a proactive and timely fashion and escalate unresolved issues and identified risks to identified roles in the company as appropriate
- Provide regular study status updatesto the CMO and during Sponsor TCs
- Create, manage and ensure tracking of study budget including revisions and perform final reconciliation at trial close out
Il candidato prescelto
- A consolidated experience executing clinical programs in medical devices/drugsclinical trials, Data Management or Clinical Monitoring
- Education: Bachelor's degree in Lifescience, Master in a health-related field is a plus
- Languages: fluent English, fluent Italian, thirdlanguage is considered a plus
- Previous experience in a pharmaceutical, CRO or medical device company required
- Sound knowledge of GCP/CFR/ICH guidelines, ISO9001,ISO14155andISO 13485
Cosa comprende l'offerta
Ottima opportunità di carriera.
Consulente
Annabella Montano
Job ref
JN-022022-5285447
Sommario dell´offerta
- Settore
- Healthcare & Life Sciences
- Settore/Ruolo
- Clinical Operations
- Settore/Funzione
- Healthcare / Pharmaceutical
- Località
- Roma e provincia
- Tipo di contratto
- Permanent
- Nome del consulente
- Annabella Montano
- Numero dell´offerta
- JN-022022-5285447
