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 assigned studies are performed on time and within budget. They partner with Sponsors, clinical teams, and statisticians to develop data collection specifications from all data sources. /p pThe Senior Data Manager manages in-stream data flow activities, delivers a quality database according to the project plan, leads and drives the data management team, and acts as the primary contact for the Sponsor and the project’s data management lead. /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 the Case Record Form and guide its approval process. /li liDefine and develop the Data Management Plan, Data Validation Plan, and annexes (e.g., Reconciliation Plan) with input from the study team. /li liValidate the database and perform computerized checks, including SAS listings or checks. /li liFor EDC studies, define the User Acceptance Test (UAT) plan and execute testing to ensure quality eCRF. /li liRespond promptly to issues identified by the eCRF Helpdesk. /li liPrepare CRF completion guidelines and study-specific data-entry guidelines; train data-entry staff. /li liPerform term coding, raise manual queries for uncoded terms as needed. /li liManage queries: review discrepancies, resolve, and close queries; oversee data cleaning. /li liCreate and test import programs for external data. /li liPerform data integration and reconciliation of external data sources. /li liMonitor study data progress, manage queries, escalate issues. /li liDefine and execute QC plans, lead database release and freeze activities. /li liLead the DM team, assign work, schedule, prioritize. /li liMonitor progress against the study plan and escalate issues. /li liContribute to training for new team members. /li liFollow SOPs, industry standards (ICH, GCP), and recommend process improvements. /li liMaintain communication with the sponsor and represent Data Management in meetings. /li liPerform other activities as required. /li /ol h3Qualifications Experience /h3 ul liBSc in life sciences, pharmacy, or related field, or at least 3 years’ experience in data management in pharma. /li liKnowledge of Data Management processes and industry guidelines (ICH, GCP). /li liKnowledge of coding dictionaries (MedDRA, WHO-DD) and DM systems. /li /ul h3Skills /h3 ul liProficiency in MS Office. /li liProfessionalism, trustworthiness, ability to prioritize, quality focus, willingness to learn. /li liTeamwork, learning agility, conflict management, problem-solving, technical writing, networking skills. /li /ul h3Education /h3 pBSc 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 and research services to humanize healthcare and life sciences, partnering with patients through innovative technologies 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 programs, and more. /p h3Join Our Team /h3 pWe are a diverse team of over 800 professionals from 30+ nationalities, committed to delivering innovative solutions that improve patient care and outcomes. Apply now or send your spontaneous application. /p #J-18808-Ljbffr