Clinical Project Manager

Roma e provincia Permanente

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