Alira Health
Job title:
Senior Data Manager
Company:
Alira Health
Job description
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 perspectiveJob DescriptionROLEThe 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.KEY RESPONSABILITIES Accountable for driving achievements of project milestones from study start up through to delivery of databaseProvide Data Management input into the protocolDesign the Case Record Form and guide process for CRF approvalDefine and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study teamValidation of the database and computerized checks, including SAS listings or SAS checksValidation of the database and computerized checks, including SAS listings or SAS checksFor EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRFFor EDC studies timely response to issues identified by the eCRF HelpdeskPrepare CRF completion guidelinesPrepare study specific data-entry guidelines and train data-entry staffPerform term coding for clinical studies, raise manual queries for uncoded terms as requiredQuery management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listingsCreate and test import programs for electronic data received from external vendorsPerform 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 teamDefine and execute QC plan, lead and execute database release and database freeze activitiesLead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizingInput into and monitor progress against study project plan and escalate issues to resolution at the appropriate levelEffectively contribute in formal training for new startersDemonstrate good application of document management process and proceduresFollow SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activitiesMake recommendations for process improvements and development of new standardsDevelop and maintain a network of contacts within the study teamLead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activitiesMaintain continuous and appropriate communication with sponsor and share with them critical and general issuesEffectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings)Conduct other activities as requiredDESIRED QUALIFICATION & EXPERIENCEDegree 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 equivalentKnowledge of Data Management processesKnowledge of pharmaceutical industry guidelines like ICH, GCPExperience in oncology studies, with focus on early phase oncology studiesKnowledge of Medidata RAVE EDC, ProficientTECHNICAL COMPETENCES & SOFT SKILLS English, GoodMS Office Suite, GoodProfessionalTrustworthyAbility to effectively prioritizeQuality focusedPersonable AttitudeWillingness to learnTeam PlayerEffective Stress Management TechniquesLearning AgilityAbility to Manage ConflictProblem Solving SkillsEffective Verbal Communication SkillsCommercial and Technical Writing SkillsNetworking SkillsLanguages EnglishEducation Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type Regular
Expected salary
Location
Verona
Job date
Wed, 18 Sep 2024 07:04:53 GMT
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