PJoin 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. /ppbJob Description Summary /b /ppThe 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. /ppThe 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. /ph3ROLE /h3pThe 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. /ppThe 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. /ph3KEY RESPONSABILITIES /h3ullipAccountable for driving achievements of project milestones from study start-up through to delivery of database. /p /lilipProvide Data Management input into the protocol. /p /lilipDesign the Case Record Form and guide process for CRF approval. /p /lilipDefine and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team. /p /lilipValidation of the database and computerized checks, including SAS listings or SAS checks. /p /lilipFor EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF. /p /lilipFor EDC studies, timely response to issues identified by the eCRF Helpdesk. /p /lilipPrepare CRF completion guidelines. /p /lilipPrepare study-specific data-entry guidelines and train data-entry staff. /p /lilipPerform term coding for clinical studies, raise manual queries for uncoded terms as required. /p /lilipQuery management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings. /p /lilipCreate and test import programs for electronic data received from external vendors. /p /lilipPerform timely data integration of CRF and non-CRF data (data import from external sources). /p /lilipPerform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc.). /p /lilipRun 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. /p /lilipDefine and execute QC plan, lead and execute database release and database freeze activities. /p /lilipLead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing. /p /lilipInput into and monitor progress against study project plan and escalate issues to resolution at the appropriate level. /p /lilipEffectively contribute in formal training for new starters. /p /lilipDemonstrate good application of document management process and procedures. /p /lilipFollow SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc. to day-to-day activities. /p /lilipMake recommendations for process improvements and development of new standards. /p /lilipDevelop and maintain a network of contacts within the study team. /p /lilipMaintain continuous and appropriate communication with sponsor and share with them critical and general issues. /p /lilipEffectively represent Data Management in internal or external meetings (e.g. Investigator’s Meetings). /p /lilipConduct other activities as required. /p /li /ulh3DESIRED QUALIFICATION EXPERIENCE /h3ullipDegree 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. /p /lilipKnowledge of Data Management processes. /p /lilipKnowledge of pharmaceutical industry guidelines like ICH, GCP etc. /p /lilipKnowledge of coding dictionaries like MedDRA and WHO-DD or equivalent. /p /lilipKnowledge in one or more DM systems. /p /li /ulh3TECHNICAL COMPETENCES SOFT SKILLS /h3ullipEnglish. /p /lilipMS Office Suite. /p /lilipProfessional. /p /lilipTrustworthy. /p /lilipAbility to effectively prioritize. /p /lilipQuality focused. /p /lilipPersonable Attitude. /p /lilipWillingness to learn. /p /lilipTeam Player. /p /lilipEffective Stress Management Techniques. /p /lilipLearning Agility. /p /lilipAbility to Manage Conflict. /p /lilipProblem Solving Skills. /p /lilipEffective Verbal Communication Skills. /p /lilipCommercial and Technical Writing Skills. /p /lilipNetworking Skills. /p /li /ulpbLanguages /b /ppEnglish /ppbEducation /b /ppBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy /ppbContract Type /b /ppRegular /ppAlira 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. /ph3Why Work at Alira Health? /h3pWith 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. /ph3Join Our Team /h3pWe 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. /ppIntroduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application. /p #J-18808-Ljbffr