Senior Data Manager

2 mesi fa

Verona, Italia Alira Health A tempo pieno

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 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

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

#J-18808-Ljbffr

  • Senior Data Manager

    2 mesi fa

    Verona, Italia Alira Health A tempo pieno

    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...

  • Senior Data Manager

    4 settimane fa

    Verona, Italia Alira Health A tempo pieno

    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

    2 mesi fa

    Verona, Italia Alira Health A tempo pieno

    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

    2 mesi fa

    Verona, Italia Alira Health A tempo pieno

    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...

  • Senior IT Data Governance Analyst

    2 settimane fa

    Verona, Veneto, Italia Michael Page A tempo pieno

    At Michael Page, we're seeking a Senior IT Data Governance Analyst to join our team in the US. This is an excellent opportunity for you to leverage your technical expertise and analytical skills to drive business growth.As a Senior IT Data Governance Analyst, you'll be responsible for developing and implementing data governance strategies that align with the...

  • Lead Data Manager

    6 mesi fa

    Verona, Italia Alira Health A tempo pieno

    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...

  • Senior Data Science Consultant

    1 settimana fa

    Verona, Italia SDG Group A tempo pieno

    SDG è alla ricerca di un Senior Data Scientist capace di gestire autonomamente progetti e risorse. Il candidato ideale possiede una solida esperienza nella creazione e implementazione di modelli analitici complessi e dimostra la capacità di coordinare le risorse assegnate per garantire il completamento efficiente e di alta qualità dei...

  • Senior Data Science Consultant

    4 giorni fa

    Verona, Italia Sdg Group A tempo pieno

    SDG è alla ricerca di un Senior Data Scientist capace di gestire autonomamente progetti e risorse.Il candidato ideale possiede una solida esperienza nella creazione e implementazione di modelli analitici complessi e dimostra la capacità di coordinare le risorse assegnate per garantire il completamento efficiente e di alta qualità dei...

  • Senior Data Science Consultant

    1 settimana fa

    Verona, Italia Sdg Group A tempo pieno

    SDG è alla ricerca di un Senior Data Scientist capace di gestire autonomamente progetti e risorse. Il candidato ideale possiede una solida esperienza nella creazione e implementazione di modelli analitici complessi e dimostra la capacità di coordinare le risorse assegnate per garantire il completamento efficiente e di alta qualità dei...

  • Risorse Umane Senior/Branch Manager

    2 mesi fa

    Verona, Veneto, Italia Eurointerim S.P.A. A tempo pieno

    Descrizione del LavoroLa figura professionale ricercata di Sales Account Senior/Branch Manager opererà all'interno della Funzione Sales di Eurointerim S.p.A. a Verona (VR) e si occuperà delle attività finalizzate allo sviluppo commerciale della filiale.La figura professionale ricercata di Sales Account Senior/Branch Manager dovrà collaborare con la...

  • Principal Data Manager

    1 mese fa

    Verona, Italia Alira Health A tempo pieno

    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 SummaryJob...

  • Sales Account Senior/Branch Manager

    3 mesi fa

    Verona, Italia Eurointerim A tempo pieno

    Eurointerim S.p.A. per nuova apertura e potenziamento organico interno ricerca un profilo professionale da inserire all'interno della Funzione Sales a Verona (VR) Sales Account Senior/Branch Manager Descrizione del lavoro: La figura professionale ricercata di Sales Account Senior/Branch Manager , inserita all'interno del proprio team di lavoro e in...

  • Sales Account Senior/Branch Manager

    1 mese fa

    Verona, Italia Eurointerim S.P.A. A tempo pieno

    Eurointerim S.p.A. per nuova apertura e potenziamento organico interno ricerca un profilo professionale da inserire all'interno della Funzione Sales a Verona (VR). Descrizione del lavoro: La figura professionale ricercata di Sales Account Senior/Branch Manager , inserita all'interno del proprio team di lavoro e in stretta collaborazione con i componenti...

  • Progetto Manager Senior

    2 settimane fa

    Verona, Veneto, Italia Hrm S.R.L. A tempo pieno

    **Descrizione dell'incarico:** Il nostro Hrm S.R.L. cerca un professionista per ricoprire il ruolo di Progetto Manager Senior. Questa figura supporterà e gestirà operativamente le attività di progetto, definendo processi e formalizzando l'avanzamento dei progetti.Il candidato ideale dovrà possedere una buona conoscenza dei processi di delivery, di system...

  • Sales Account Senior/Branch Manager

    1 mese fa

    Verona, Italia Eurointerim S.p.A. A tempo pieno

    Eurointerim S.p.A. per nuova apertura e potenziamento organico interno ricerca un profilo professionale da inserire all'interno della Funzione Sales a Verona (VR). Descrizione del lavoro: La figura professionale ricercata di Sales Account Senior/Branch Manager , inserita all'interno del proprio team di lavoro e in stretta collaborazione con i componenti...

  • Esg - Sustainability Senior Consultant/Manager- Veneto

    4 giorni fa

    Verona, Italia Page Personnel Italia Spa A tempo pieno

    Autore annuncio: Page Personnel Italia spaZona lavoro: Verona e provinciaData pubblicazione: 21 dicembre 2024Descrizione offerta:Categoria: Business ServicesLuogo di lavoro: Verona e provinciaPer primaria società di consulenza, selezioniamo una risorsa di Senior Consultant/Manager che si inserirà nel team basato in Veneto, con un focus su tematiche di...

  • Esg - Sustainability Senior Consultant/Manager- Veneto

    4 giorni fa

    Verona, Italia Page Personnel Italia Spa A tempo pieno

    Autore annuncio: Page Personnel Italia spa Zona lavoro: Verona e provincia Data pubblicazione: 21 dicembre 2024 Descrizione offerta: Categoria: Business Services Luogo di lavoro: Verona e provincia Per primaria società di consulenza , selezioniamo una risorsa di Senior Consultant/Manager che si inserirà nel team basato in Veneto , con un focus su tematiche...

  • Sales Account Senior/Branch Manager

    4 settimane fa

    Verona, Italia Eurointerim spa A tempo pieno

    Categoria: COMMERCIALE E VENDITE Luogo di lavoro: Verona (VR) Eurointerim S.p.A. per nuova apertura e potenziamento organico interno ricerca un profilo professionale da inserire all'interno della Funzione Sales a Verona (VR). Sales Account Senior/Branch Manager Descrizione del lavoro: La figura professionale ricercata di Sales Account Senior/Branch...

  • Data Analytics Business Growth Manager

    4 settimane fa

    Verona, Veneto, Italia Page Executive A tempo pieno

    About Page ExecutivePage Executive is a leading global management consulting firm specializing in business analytics and data management. Our team of experts helps clients identify, qualify, cultivate, and close new business opportunities.Job Description:We are seeking a seasoned Data Analytics Business Growth Manager to join our team.The Ideal Candidate:A...

  • Senior Export Manager Food

    4 settimane fa

    Verona, Italia Buscojobs A tempo pieno

    In Job S.p.A. - Career Center di Verona seleziona SENIOR EXPORT MANAGER per realtà operante nel settore Food & Beverage Mansioni Gestire le relazioni con i clienti assegnati (principalmente retailers europei e distributori), assicurandone la fidelizzazione.Pianificare le azioni di vendita (in base alle priorità concordate con la Direzione Vendite) per...