PJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. All contributions and new ideas are explored with an open mind, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others. /ph3Job Description Summary /h3pThe Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop the data collection specifications from all data sources. /ppThe Senior Data Manager manages in-stream data flow activities, delivers a quality database according to the project plan, leads and drives the DM team, and acts as the reference point for the Sponsor and the project’s data management lead. /ph3Role /h3pThe Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop the data collection specifications from all data sources. /ppThey manage in-stream data flow activities, deliver a quality database, lead the DM team, and serve as the primary contact for the Sponsor from a data management perspective. /ph3Key Responsibilities /h3ulliDrive achievement of project milestones from study start-up to database delivery. /liliProvide Data Management input into the protocol. /liliDesign the Case Record Form and guide the CRF approval process. /liliDefine and develop Data Management and Validation Plans, including reconciliation procedures. /liliValidate the database and perform computerized checks, including SAS listings or checks. /liliFor EDC studies, define UAT plans and execute testing to ensure quality eCRFs. /liliRespond promptly to issues identified by the eCRF Helpdesk. /liliPrepare CRF completion and data-entry guidelines and train staff accordingly. /liliPerform term coding, raise queries for uncoded terms, and manage discrepancies and data cleaning processes. /liliCreate and test import programs for external data. /liliPerform data reconciliation and monitor study data progress reports. /liliDefine and execute QC plans, lead database release activities, and manage database freeze activities. /liliLead and coordinate the DM team, assign work, and prioritize tasks. /liliMonitor progress against study plans and escalate issues as needed. /liliContribute to training new team members and follow SOPs and industry standards. /liliRecommend process improvements and develop new standards. /liliMaintain communication with the study team and represent Data Management in meetings. /li /ulh3Desired Qualifications Experience /h3ulliBachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of relevant experience. /liliKnowledge of Data Management processes and industry guidelines like ICH, GCP. /liliKnowledge of coding dictionaries such as MedDRA and WHO-DD. /liliExperience with DM systems. /li /ulh3Technical Competencies Soft Skills /h3ulliProficiency in MS Office. /liliProfessionalism, trustworthiness, and effective prioritization. /liliQuality focus, willingness to learn, teamwork, learning agility, conflict management, problem-solving, technical writing, and networking skills. /li /ulh3Education /h3pBSc in Biology, Life Sciences, or Pharmacy. /ph3Contract Type /h3pRegular /ph3About Alira Health /h3pAlira Health is a global advisory firm providing consulting and research services in healthcare and life sciences, committed to humanizing healthcare through innovation and expertise. /ph3Why Work at Alira Health? /h3pWe offer a vibrant, creative environment with benefits like professional development, global travel, flexible work, and more. Join our diverse team of over 800 professionals from 30+ nationalities, dedicated to innovative solutions and improved patient care. /ph3Join Our Team /h3pApply to our open positions or send a spontaneous application to connect with our recruiters. We look forward to your application! /p #J-18808-Ljbffr