Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Our environment fosters the exploration of all contributions and new ideas with an open mind, driven by shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.
Job Description Summary
The Senior Data Manager ensures that data management tasks for assigned studies are performed on time and within budget. They collaborate with Sponsors, clinical, and statistics teams to develop data collection specifications from all data sources.
The Senior Data Manager oversees 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.
Responsibilities
* Drive achievement of project milestones from study start-up to database delivery.
* Contribute data management input into study protocols.
* Design Case Record Forms and guide their approval process.
* Develop Data Management and Validation Plans, including annexes like Reconciliation Plans.
* Validate databases and perform computerized checks, including SAS listings.
* For EDC studies, define UAT plans and execute testing to ensure quality eCRFs.
* Respond promptly to issues from the eCRF Helpdesk.
* Prepare CRF completion and data entry guidelines, and train staff accordingly.
* Perform term coding and manual query generation as needed.
* Manage data queries, discrepancies, and cleaning processes.
* Create and test import programs for external data.
* Integrate and reconcile external data sources.
* Monitor data progress reports and escalate issues.
* Define and execute QC plans, lead database release activities.
* Lead and coordinate the DM team, assign work, and prioritize tasks.
* Contribute to study project planning and communication with stakeholders.
* Ensure compliance with SOPs, industry standards, and quality procedures.
* Recommend process improvements and develop standards.
* Maintain contact networks within the study team and with sponsors.
* Represent Data Management in meetings and other activities.
Qualifications & Experience
* Bachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of relevant experience.
* Knowledge of data management processes and industry guidelines (ICH, GCP).
* Experience with coding dictionaries like MedDRA and WHO-DD.
* Proficiency in DM systems and MS Office Suite.
Skills
* Professionalism, trustworthiness, and quality focus.
* Effective prioritization, learning agility, and teamwork.
* Conflict management, problem-solving, and technical writing skills.
* Networking and language skills as applicable.
Education
BSc in Biology, Life Sciences, or Pharmacy preferred.
Contract Type
Regular
About Alira Health
Alira Health is a global advisory firm committed to humanizing healthcare and life sciences through innovative technologies and expert guidance, supporting clients across the entire solutions lifecycle.
Why Work at Alira Health?
We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work programs, and more. Join us and bring your passion, talent, and entrepreneurial spirit.
Join Our Team
Be part of a diverse team of over 800 professionals from more than 30 nationalities. Apply to our open positions or send a spontaneous application to connect with our recruiters.
#J-18808-Ljbffr