Join 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.Job Description SummaryThe 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 specification from all data sources. The Senior Data Manager manages in-stream data flow activities, 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 project data management lead.ResponsibilitiesDrive achievement of project milestones from study start-up through database delivery.Provide Data Management input into the protocol.Design the Case Record Form and guide the CRF approval process.Define and develop the Data Management Plan, Data Validation Plan, and their annexes.Validate the database and computerized checks, including SAS listings or checks.For EDC studies, define the User Acceptance Test Plan (UAT) and execute test activities to ensure quality eCRF.Respond promptly to issues identified by the eCRF Helpdesk.Prepare CRF completion guidelines and study-specific data-entry guidelines; train data-entry staff.Perform term coding, raise manual queries for uncoded terms.Manage queries, review discrepancies, resolve and close queries, and oversee data cleaning.Create and test import programs for external data.Perform data integration and reconciliation of external data sources.Monitor study data progress reports, manage query resolution, and escalate issues.Define and execute QC plans, lead database release and freeze activities.Lead the DM team, assign work, prioritize tasks, and monitor progress.Contribute to training and ensure adherence to SOPs, industry standards like ICH, GCP.Recommend process improvements and develop new standards.Develop and maintain contacts within the study team and represent Data Management in meetings.Perform other activities as required.Qualifications & ExperienceBachelor's degree in life sciences, pharmacy, or related field, or at least 5 years' experience in data management within a pharmaceutical environment.Knowledge of Data Management processes, industry guidelines (ICH, GCP).Experience in oncology studies, especially early phase.Proficiency in Medidata RAVE EDC.Technical Skills & Soft SkillsProficient in English and MS Office Suite.Trustworthy, quality-focused, personable, willing to learn, team player.Effective stress management, learning agility, conflict management, problem-solving skills.Effective verbal and technical writing skills, networking skills.EducationBSc in Biology, Life Sciences, or Pharmacy.Contract TypeRegular
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