Senior Data Manager

col-wideJob 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 SummaryJob DescriptionROLE 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 sourcesThe 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 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 & EXPERIENCE Degree in life science, pharmaceutical, biology or related fieldBased in EuropeMinimum of 6-8 years of data management experienceExperience in OncologyCRO experienceProficiency with either Medidata or Merative ZeltaExperience 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 selectionExperience with eCOA/ePRO not mandatory but it will be an added value for the selectionKnowledge of pharmaceutical industry guidelines like ICH, GCP etc , GoodKnowledge of coding dictionaries like MedDRA and WHO-DD or equivalent, GoodTECHNICAL COMPETENCES & SOFT SKILLS MS Office Suite, GoodProfessionalTrustworthyAbility to effectively prioritizeQuality focusedWillingness to learnTeam PlayerLearning AgilityAbility to Manage ConflictProblem Solving SkillsCommercial and Technical Writing SkillsNetworking SkillsLanguagesEnglish EducationBachelor 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 SummaryJob DescriptionROLE 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 sourcesThe 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 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 & EXPERIENCE Degree in life science, pharmaceutical, biology or related fieldBased in EuropeMinimum of 6-8 years of data management experienceExperience in OncologyCRO experienceProficiency with either Medidata or Merative ZeltaExperience 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 selectionExperience with eCOA/ePRO not mandatory but it will be an added value for the selectionKnowledge of pharmaceutical industry guidelines like ICH, GCP etc , GoodKnowledge of coding dictionaries like MedDRA and WHO-DD or equivalent, GoodTECHNICAL 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 SkillsLanguagesEnglish EducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy Contract TypeRegularAbout 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.Introduce yourself to our Recruiters Apply to one of our open jobs or send us your spontaneous application.#J-18808-Ljbffr