Senior Data Manager

3 settimane fa

Bologna, Italia Alira Health Group 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 delivers a quality database in accordance with the project plan, leads and drives 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.

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 delivers a quality database in accordance with the project plan, leads and drives 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.

  • 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 the 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.

  • Maintain continuous and appropriate communication with sponsor and share with them critical and general issues.

  • Effectively represent 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 3 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 etc.

  • Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent.

  • Knowledge in one or more DM systems.

TECHNICAL COMPETENCES & SOFT SKILLS

  • English.

  • MS Office Suite.

  • 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

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

Introduce yourself to our Recruiters Apply to one of our open jobs or send us your spontaneous application.

#J-18808-Ljbffr

  • Senior Data Manager

    3 settimane fa

    BOLOGNA, Italia Alira Health Group 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 SummaryThe...

  • Senior Data Manager

    3 settimane fa

    BOLOGNA, Italia Alira Health Group 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...

  • Senior Data Manager

    2 settimane fa

    BOLOGNA, Italia Alira Health Group 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 ...

  • Senior Data Manager

    3 settimane fa

    Bologna, Italia Alira Health Group 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 Engineer

    3 settimane fa

    BOLOGNA, Italia Crif A tempo pieno

    CRIF, prestigioso ed innovativo Gruppo internazionale specializzato in soluzioni informative, modelli decisionali, outsourcing, software e servizi consulenziali per supportare banche, società finanziarie, assicurazioni, utilities e imprese in ogni fase della relazione con il cliente, ricerca all'interno dell'area di Global Advanced Analytics, Centro di...

  • Senior Data Engineer

    3 settimane fa

    Bologna, Italia CRIF A tempo pieno

    CRIF, prestigioso ed innovativo Gruppo internazionale specializzato in soluzioni informative, modelli decisionali, outsourcing, software e servizi consulenziali per supportare banche, società finanziarie, assicurazioni, utilities e imprese in ogni fase della relazione con il cliente, ricerca all’interno dell’area di Global Advanced Analytics, Centro...

  • Senior Data Engineer

    2 settimane fa

    Bologna, Emilia-Romagna, Italia Avanade A tempo pieno

    Descrizione del RuoloNel ruolo di Senior PowerBI Specialist per la familia Analytics Experience, contribuirai attivamente alla progettazione e realizzazione di piattaforme complesse di BI e reporting, con focus particolare sulla scalabilità ed efficienza della soluzione in contesto Cloud e On Premise. I clienti si rivolgono a noi per l'innovazione: avrai...

  • Progetto IT Manager Senior

    4 settimane fa

    Bologna, Emilia-Romagna, Italia Techyon S.R.L. A tempo pieno

    Il nostro progettoTechyon è un leader nel settore IT e stiamo cercando un Progetto IT Manager Senior per affrontare i nostri obiettivi di crescita e innovazione.Il nostro Recruitment Engineer seleziona i migliori profili IT per prestigiose società di consulenza informatica, banche, aziende di servizi, gruppi manifatturieri e start-up di eccellenza.Il...

  • Senior Data Engineer Consultant

    1 mese fa

    BOLOGNA, Italia Iconsulting S.P.A. A tempo pieno

    Descrizione azienda Siamo una Data-Driven Transformation & Consulting Company con oltre 20 anni di esperienza, specializzata nella gestione e trasformazione del più prezioso asset del mercato odierno: i DATI.Con un team di 500 professionisti distribuiti su quattro sedi (Bologna HQ, Milano, Roma, Napoli), supportiamo l'evoluzione di grandi aziende, italiane...

  • Data Analytics Manager

    5 mesi fa

    Bologna, Italia GELLIFY A tempo pieno

    We are a **global innovation factory** that integrates strategy, design & technology, supporting companies’ growth from vision to execution in a “purple way”. We help organizations implement **new business models, technology roadmaps, digital strategies & products, powered by our B2B software assets.** We firmly believe that **people are the real...

  • Senior Data Analyst, Global Privacy

    3 settimane fa

    Bologna, Emilia-Romagna, Italia The Sherwin-Williams Company A tempo pieno

    "A key member of our team is sought to lead and implement our global data protection strategy, ensuring the highest standards of data security and compliance across all regions," said [Company Name].**Job Summary**We are seeking a highly skilled and experienced Senior Data Analyst, Global Privacy to join our team. The ideal candidate will be responsible for...

  • Senior Manager

    4 settimane fa

    Bologna, Emilia-Romagna, Italia Oilandgas.Org A tempo pieno

    Descrizione del RuoloSiamo alla ricerca di un Senior Manager che possa supportare la Senior Leadership della nostra Practice nelle seguenti attività:Gestione autonoma dei progettiIndirizzamento e autorità della relativa deliveryGestione e sviluppo dei clienti assegnatiGenerazione di nuove opportunità e clienti valorizzando l'offering completo di BIP e il...

  • Senior Data Analyst

    3 settimane fa

    Bologna, Emilia-Romagna, Italia Eos Spa A tempo pieno

    La nostra azienda, Eos Spa, è leader nelle soluzioni gestionali ERP e CRM Microsoft. Ricerchiamo un Senior Business Intelligence Consultant per la nostra sede di Bologna. La candidata o il candidato ideale avrà un'esperienza quinquennale nel ruolo di Business Intelligence Consultant e sarà inserita nella Business Unit Controlling & Analytics.Le...

  • Lead Data Manager

    2 giorni fa

    BOLOGNA, Italia Buscojobs A tempo pieno

    7 giorni fa We're over 2,700+ strong across the globe.We're scientists, strategists, creatives, and innovators.We value individual brilliance and build a strong foundation for teamwork across all our business.We love the challenge of our industry.We're changing lives and redefining success every step of the way.Job Description The Lead Data Manager will be...

  • Lead Data Manager

    2 giorni fa

    BOLOGNA, Italia Buscojobs A tempo pieno

    7 giorni faWe're over 2,700+ strong across the globe. We're scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We're changing lives and redefining success every step of the way.Job Description The Lead Data Manager will...

  • Senior Agile Delivery Manager

    7 giorni fa

    Bologna, Italia Qubica Holdings s.r.l. A tempo pieno

    QubicaAMF is a mid-cap operating at the intersection of software, technology, manufacturing, sport, and entertainment, the worldwide product and technology leader in its space with 45% market share.QubicaAMF has defined a crystal-clear vision to accelerate future growth largely based on accelerated research and development investments and an aggressive...

  • Senior Agile Delivery Manager

    3 settimane fa

    BOLOGNA, Italia Qubica Holdings S.R.L. A tempo pieno

    QubicaAMF is a mid-cap operating at the intersection of software, technology, manufacturing, sport, and entertainment, the worldwide product and technology leader in its space with 45% market share.QubicaAMF has defined a crystal-clear vision to accelerate future growth largely based on accelerated research and development investments and an aggressive...

  • Data Science Leader

    5 mesi fa

    Bologna, Italia CRIF A tempo pieno

    CRIF prestigioso ed innovativo Gruppo internazionale specializzato in soluzioni informative, modelli decisionali, outsourcing, software e servizi consulenziali a supporto di banche, società finanziarie, assicurazioni, utilities e imprese, ricerca una figura di: **Data Science Leader** La risorsa sarà inserita nell’area “Advanced Analytics Global” è...

  • Senior Contabile Auditing Manager

    3 settimane fa

    Bologna, Emilia-Romagna, Italia Relizont A tempo pieno

    Ruolo di Senior Contabile Auditing ManagerStiamo cercando un professionista esperto per occuparsi della revisione e controllo delle nostre attività finanziarie. La risorsa ideale avrà minimo 3 anni di esperienza specifica nella revisione contabile e sarà in grado di gestire i processi di revisione e due diligence con competenza eefficacia.Le principali...

  • Senior Agile Delivery Manager

    3 settimane fa

    Bologna, Italia Qubica Holdings s.r.l. A tempo pieno

    QubicaAMF is a mid-cap operating at the intersection of software, technology, manufacturing, sport, and entertainment, the worldwide product and technology leader in its space with 45% market share. QubicaAMF has defined a crystal-clear vision to accelerate future growth largely based on accelerated research and development investments and an aggressive...