Alira Health
Job title:
Principal, 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 Principal 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 DescriptionROLEThe Principal Data Manager leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sourcesThe Principal Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, makes recommendation for process improvement and/or new standards development.The Principal Data Manager is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets.KEY RESPONSABILITIESAccountable for driving achievement 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 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 executive 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 proritisingInput into and monitor progress against study project plan and escalate issues to resolution at the appropriate levelProven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutionsDemonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDMEducate/train on use of study specific data collection tool(s) and query management processEffectively contribute in formal training for new startersMake recommendations for process improvements and development of new standardsMaintain continuous and appropriate communication with sponsors and share with them critical and general issuesEffective relationship management with vendors and customers in order to meet expectations and achieve resultsEffectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings)Conducts other activities as requiredDESIRED QUALIFICATION & EXPERIENCEDegree in life science, pharmaceutical, biology or related field or at least 6 years’ experience in data management field or similar in a pharmaceutical environment or equivalentKnowledge of Data Management processes, Very GoodKnowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very GoodExpert in one or more DM systems or processes and recognized for their expertiseAble to propose standards across studies and therapeutic areasProficiency in Medidata Rave or Merative ZeltaOncology experienceTECHNICAL COMPETENCES & SOFT SKILLSEnglish, Very 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 SkillsAnalytical thinkingResilientAbility to Influence and motivateAbility to manage difficult conversationsInnovativeAbility to Provide Constructive FeedbackExcellent Presentation SkillsCommercial awarenessAbility to recognize and develop talentLanguages EnglishEducation Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacologyContract Type Contingency Workforce
Expected salary
Location
France
Job date
Fri, 01 Nov 2024 06:34:23 GMT
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