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 that data management tasks for assigned studies are performed on time and within budget. They collaborate with sponsors, clinical teams, and statisticians to develop data collection specifications from all data sources.This role manages in-stream data flow activities, delivers high-quality databases according to the project plan, leads and drives the data management team, and serves as the primary contact for the sponsor and the project’s data management lead.Key ResponsibilitiesDrive achievement of project milestones from study start-up to database delivery.Provide data management input into study protocols.Design Case Record Forms (CRFs) and oversee the approval process.Develop Data Management Plans, Validation Plans, and annexes, with input from the study team.Validate databases and perform computerized checks, including SAS listings.Define and execute User Acceptance Testing (UAT) plans for EDC studies.Respond promptly to issues from the eCRF Helpdesk.Prepare CRF completion and data-entry guidelines and train staff.Perform term coding and manual query management, including discrepancy resolution.Create and test import programs for electronic data from external vendors.Manage data integration and reconciliation of external data sources.Monitor study data progress, manage queries, and escalate issues as needed.Lead database release activities and coordinate team work assignments.Contribute to training for new team members and adhere to SOPs and industry standards.Recommend process improvements and develop new standards.Maintain communication with the study team and sponsor, representing data management in meetings.Perform other activities as required.Desired Qualifications & ExperienceBachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of experience in data management within the pharmaceutical industry.Knowledge of data management processes, industry guidelines (ICH, GCP), and coding dictionaries (MedDRA, WHO-DD).Experience with DM systems and MS Office Suite.Technical Skills & Soft SkillsProfessional, trustworthy, and quality-focused.Effective prioritization, learning agility, and conflict management skills.Problem-solving, technical writing, and networking skills.Willingness to learn and team-oriented attitude.EducationBSc in Biology, Life Sciences, or Pharmacy.Contract TypeRegularAbout Alira HealthAlira Health is a global advisory firm providing consulting, research, and clinical development services, committed to humanizing healthcare and life sciences through innovative technologies and expert guidance.Why Work at Alira Health?We offer a vibrant environment with professional development opportunities, global travel, flexible work programs, and more. Join our diverse team of over 800 professionals from 30+ nationalities, impacting healthcare worldwide.Join Our TeamApply to our open positions or send a spontaneous application to become part of our innovative team.
#J-18808-Ljbffr