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 Summary
The Senior Data Manager ensures DM tasks for assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop the data collection specifications from all data sources.
The Senior Data Manager manages in-stream data flow activities, delivers a quality database per the project plan, leads the DM team, and acts as the reference point for the Sponsor and the project’s data management lead.
Role
The Senior Data Manager ensures timely and budget-compliant execution of DM tasks, collaborates to develop data collection specifications, manages data flow activities, and leads the DM team, serving as the primary contact for data management aspects of the project.
Key Responsibilities
* Drive achievement of project milestones from start-up to database delivery.
* Provide Data Management input into the protocol.
* Design CRFs and guide their approval process.
* Develop Data Management and Validation Plans, including reconciliation plans.
* Validate databases and perform computerized checks, including SAS listings.
* Define and execute UAT plans for EDC studies, ensuring quality eCRF.
* Respond promptly to eCRF Helpdesk issues.
* Prepare CRF completion and data-entry guidelines and train staff.
* Perform term coding and raise queries for uncoded terms.
* Manage queries, discrepancies, and data cleaning processes.
* Create and test data import programs from external vendors.
* Integrate and reconcile external data sources.
* Monitor data progress reports, escalate issues, and manage study data activities.
* Lead DM team, assign work, and prioritize tasks.
* Contribute to training and document management processes.
* Follow SOPs, industry standards, and recommend process improvements.
* Maintain communication with the study team and sponsor, representing Data Management in meetings.
* Perform additional activities as required.
Desired Qualifications & Experience
* Degree in life sciences, pharmacy, or related field, or 3+ years in data management in pharma.
* Knowledge of Data Management processes, industry guidelines, and coding dictionaries.
* Experience with DM systems.
* Proficiency in MS Office.
* Trustworthiness, professionalism, and effective prioritization.
* Focus on quality, learning agility, teamwork, conflict management, problem-solving, and networking skills.
Education
BSc in Biology, Life Sciences, or Pharmacy.
Contract Type
Regular
Alira Health is a global advisory firm dedicated to humanizing healthcare and life sciences through innovative technology and expert guidance. We offer comprehensive services across the healthcare solutions lifecycle.
Why Work at Alira Health?
With offices worldwide, we provide a vibrant environment with benefits like professional development, global travel, and flexible work arrangements. We value passion, talent, entrepreneurial spirit, and teamwork.
Join Our Team
We are a diverse team of over 800 professionals from more than 30 nationalities. Apply to our open positions or send a spontaneous application. Introduce yourself to our recruiters!
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