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Senior Data Manager

3 mesi fa

Verona, Italia Alira Health Srl 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 Job Description ROLE The Senior Data Manager e nsure s DM tasks for the assigned studies are performed on time and within budget , p artner s with Sponsors, clinical and statistics to develop the data collection specification from all data sources
The Senior Data Manager m anage s in-stream data flow activities and deliver a quality database in accordance with the project plan , l ead s and drive the DM team , and a ct s 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
Based in Europe
Minimum of 6-8 years of data management experience
Experience in Oncology
CRO experience
Proficiency with either Medidata or Merative Zelta
Experience as Lead Data Manager but with solid background of hands-on work like writing DMP, DVP, query management etc, from Start up up to database lock.
Experience with management of non CRF data (eg Central lab, PK, Biomarkers, Imaging)
Experience with IRT, not mandatory but it will be an added value for the selection
Experience with eCOA/ePRO not mandatory but it will be an added value for the selection
Knowledge of pharmaceutical industry guidelines like ICH, GCP etc , Good
Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent, Good

TECHNICAL COMPETENCES & SOFT SKILLS  MS Office Suite, Good
Professional 
Trustworthy
Ability to effectively prioritize
Quality focused
Willingness to learn
Team Player
Learning Agility
Ability to Manage Conflict 
Problem Solving Skills
Commercial and Technical Writing Skills
Networking Skills
Languages
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy 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 Job Description ROLE The Senior Data Manager e nsure s DM tasks for the assigned studies are performed on time and within budget , p artner s with Sponsors, clinical and statistics to develop the data collection specification from all data sources
The Senior Data Manager m anage s in-stream data flow activities and deliver a quality database in accordance with the project plan , l ead s and drive the DM team , and a ct s 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
Based in Europe
Minimum of 6-8 years of data management experience
Experience in Oncology
CRO experience
Proficiency with either Medidata or Merative Zelta
Experience as Lead Data Manager but with solid background of hands-on work like writing DMP, DVP, query management etc, from Start up up to database lock.
Experience with management of non CRF data (eg Central lab, PK, Biomarkers, Imaging)
Experience with IRT, not mandatory but it will be an added value for the selection
Experience with eCOA/ePRO not mandatory but it will be an added value for the selection
Knowledge of pharmaceutical industry guidelines like ICH, GCP etc , Good
Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent, Good

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
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type
Regular
About Us 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.
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