72
lavori presso Dm in località Italia
Senior Data Manager
Voglio ricevere notifiche sulle ultime opportunità lavorative presso Dm.
Operator
Operator
Operator
Fire Prevention Engineer
Ingegnere edile junior
Docente per corsi di formazione antincendio D.Lgs. 81/08 e D.M. 02/09/2021 - Reggio Emilia
Docente per corsi di formazione antincendio D.Lgs. 81/08 e D.M. 02/09/2021 - Reggio Emilia
Noesi Evolution s.r.l.
Reggio Emilia
EUR 30.000 - 50.000
Richiesta urgente
Ieri
Direttore Operativo
Collegati con i cacciatori di teste per candidarti a posizioni similiinsegnante scuola dell'infanzia
insegnante scuola dell'infanzia
La Nuvola nel Sacco Società Cooperativa Sociale
Busnago
EUR 10.000 - 30.000
Direttore Operativo
BIM COORDINATOR
Formatore lingua Inglese
Formatore Discipline STEM
ADDETTI SECURITY
ADDETTI SECURITY
Principal Data Manager
Insegnanti scuole dell'infanzia Provincia di Lodi
Insegnanti scuole dell'infanzia Provincia di Lodi
Società cooperativa sociale Il Mosaico Servizi ETS
Lodi
EUR 30.000 - 50.000
Tecnico sanitario di radiologia medica
CONSULENTE TECNICO SICUREZZA – PREVENZIONE INCENDI
PROJECT MANAGER PER IMPIANTI MECCANICI ELETTRICI E DI AUTOMAZIONE
PROJECT MANAGER PER IMPIANTI MECCANICI ELETTRICI E DI AUTOMAZIONE
Orienta Filiale di Torino
Aosta
EUR 50.000 - 70.000
Richiesta urgente
Oggi
PROJECT MANAGER PER IMPIANTI MECCANICI ELETTRICI E DI AUTOMAZIONE
PROJECT MANAGER PER IMPIANTI MECCANICI ELETTRICI E DI AUTOMAZIONE
Orienta Filiale di Torino
Borgaro Torinese
EUR 50.000 - 70.000
Richiesta urgente
Oggi
Responsabile tecnico - Energia
Principal Statistical Programmer
OPERATORI CONTROL ROOM LINEE METROPOLITANE AUTOMATICHE
OPERATORI CONTROL ROOM LINEE METROPOLITANE AUTOMATICHE
Azienda Trasporti Milanesi SPA
Milano
EUR 10.000 - 30.000
Richiesta urgente
Ieri
OPERATORI CONTROL ROOM LINEE METROPOLITANE AUTOMATICHE
OPERATORI CONTROL ROOM LINEE METROPOLITANE AUTOMATICHE
Azienda Trasporti Milanesi S.p.A
Milano
EUR 10.000 - 30.000
Richiesta urgente
Ieri
Senior Data Manager
Alira Health
Verona
EUR 70.000 - 90.000
Descrizione del lavoro
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sourcesThe Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective
Job Description
ROLE
The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources
The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective.
KEY RESPONSABILITIES
Accountable for driving achievements of project milestones from study start up through to delivery of database
Provide Data Management input into the protocol
Design the Case Record Form and guide process for CRF approval
Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team
Validation of the database and computerized checks, including SAS listings or SAS checks
Validation of the database and computerized checks, including SAS listings or SAS checks
For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF
For EDC studies timely response to issues identified by the eCRF Helpdesk
Prepare CRF completion guidelines
Prepare study specific data-entry guidelines and train data-entry staff
Perform term coding for clinical studies, raise manual queries for uncoded terms as required
Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings
Create and test import programs for electronic data received from external vendors
Perform timely data integration of CRF and non CRF data (data import from external sources)
Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc)
Run and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team
Define and execute QC plan, lead and execute database release and database freeze activities
Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing
Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
Effectively contribute in formal training for new starters
Demonstrate good application of document management process and procedures
Follow SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities
Make recommendations for process improvements and development of new standards
Develop and maintain a network of contacts within the study team
Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities
Maintain continuous and appropriate communication with sponsor and share with them critical and general issues
Effectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings)
Conduct other activities as required
DESIRED QUALIFICATION & EXPERIENCE
Degree in life science, pharmaceutical, biology or related field or at least 5 years’ experience in data management field or similar in a pharmaceutical environment or equivalent
Knowledge of Data Management processes
Knowledge of pharmaceutical industry guidelines like ICH, GCP
Experience in oncology studies, with focus on early phase oncology studies
Knowledge of Medidata RAVE EDC, Proficient
TECHNICAL COMPETENCES & SOFT SKILLS
English, Good
MS Office Suite, Good
Professional
Trustworthy
Ability to effectively prioritize
Quality focused
Personable Attitude
Willingness to learn
Team Player
Effective Stress Management Techniques
Learning Agility
Ability to Manage Conflict
Problem Solving Skills
Effective Verbal Communication Skills
Commercial and Technical Writing Skills
Networking Skills
Languages
English
Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy
Contract Type
Regular
* Il benchmark retributivo si basa sugli obiettivi retributivi dei leader del mercato nei rispettivi settori. È pensato per orientare gli utenti Premium nella valutazione delle posizioni aperte e aiutarli a negoziare la propria retribuzione. Tale benchmark non è fornito direttamente dall'azienda, quindi la retribuzione effettiva potrà risultare anche notevolmente superiore o inferiore.
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