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. /p h3Job Description Summary /h3 pThe Senior Data Manager ensures data management tasks for the assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop data collection specifications from all data sources. /p pThe Senior Data Manager manages in-stream data flow activities, delivers a quality database in accordance with the project plan, leads and drives the data management team, and acts as the reference point for the Sponsor and the project’s data management lead. /p h3Role /h3 pThe Senior Data Manager ensures data management tasks are performed efficiently, partners with relevant teams to develop specifications, manages data flow activities, and leads the data management team, serving as the primary contact for data management from the sponsor’s perspective. /p h3Key Responsibilities /h3 ol liDrive achievement of project milestones from study start-up through database delivery. /li liProvide data management input into the protocol. /li liDesign Case Record Forms and guide CRF approval processes. /li liDefine and develop Data Management and Validation Plans, including reconciliation and other annexes. /li liValidate databases and perform computerized checks, including SAS listings. /li liFor EDC studies, define UAT plans and execute testing to ensure quality eCRFs. /li liRespond promptly to issues from the eCRF Helpdesk. /li liPrepare CRF completion and data-entry guidelines, and train staff accordingly. /li liPerform term coding, raise queries, and manage data cleaning processes. /li liCreate and test import programs for electronic data from external vendors. /li liPerform data reconciliation and integration from external sources. /li liMonitor study data progress, manage queries, and escalate issues as needed. /li liDefine and execute QC plans, lead database releases and freezes. /li liLead and coordinate the data management team, assign work, and prioritize tasks. /li liMonitor study progress, escalate issues, and contribute to training. /li liEnsure adherence to SOPs, industry standards, and best practices. /li liDevelop contacts within the study team and maintain communication with sponsors. /li liRepresent data management in meetings and other activities. /li /ol h3Desired Qualifications Experience /h3 pDegree in life sciences or related field, or at least 3 years’ experience in data management in a pharmaceutical environment. Knowledge of industry guidelines (ICH, GCP), coding dictionaries (MedDRA, WHO-DD), and DM systems. /p h3Technical Competencies Soft Skills /h3 ul liEnglish proficiency /li liMS Office skills /li liProfessionalism, trustworthiness, and teamwork /li liPrioritization, quality focus, and learning agility /li liStress and conflict management /li liProblem-solving and communication skills /li liNetworking skills /li /ul h3Education /h3 pBachelor’s degree in Biology, Life Sciences, or Pharmacy. /p h3Contract Type /h3 pRegular /p h3About Alira Health /h3 pAlira Health is a global advisory firm providing consulting, research, and clinical development services, committed to humanizing healthcare and life sciences through innovative solutions and expert guidance. /p h3Why Work at Alira Health? /h3 pWith offices worldwide, we offer a vibrant environment with benefits including professional development, global travel, flexible work arrangements, and more. We value passion, talent, entrepreneurial spirit, and teamwork. /p h3Join Our Team /h3 pOur team includes over 800 professionals from 30+ nationalities. We invite you to apply to our open positions or send a spontaneous application. /p #J-18808-Ljbffr