Senior Data Manager
Descrizione dell'offerta
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is 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 the 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 in accordance with the project plan, leads and drives 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 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 specifications 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 project’s data management lead.
Key Responsibilities
- Drive achievement of project milestones from study start-up to 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 annexes (e.g., Reconciliation Plan) with input from the study team.
- Validate the database and computerized checks, including SAS listings or checks.
- For EDC studies, define the User Acceptance Test Plan (UAT) and execute testing 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 queries for uncoded terms.
- Manage queries: review discrepancies, resolve, and close queries; manage data cleaning.
- Create and test import programs for electronic data from external vendors.
- Perform data integration and reconciliation of external data sources.
- Monitor study data progress reports, escalate issues, and take corrective actions.
- Define and execute QC plans, lead database release and freeze activities.
- Lead the DM team, assign work, schedule, and prioritize tasks.
- Monitor progress against study plans and escalate issues.
- Contribute to training for new team members.
- Follow SOPs, industry standards (ICH, GCP), and recommend process improvements.
- Maintain communication with the study team and sponsor, represent Data Management in meetings.
- Conduct other activities as required.
Desired Qualifications & Experience
- Bachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years’ experience in data management in pharma.
- Knowledge of Data Management processes and industry guidelines (ICH, GCP).
- Familiarity with coding dictionaries (MedDRA, WHO-DD) and DM systems.
Technical Competencies & Soft Skills
- Proficiency in MS Office Suite.
- Professionalism, trustworthiness, ability to prioritize, quality focus, willingness to learn, teamwork, learning agility, conflict management, problem-solving, technical and business writing, networking skills.
Education
Bachelor of Science in Biology, Life Sciences, or Pharmacy.
Contract Type
Regular
About Alira Health
Alira Health is a global consulting, research, and clinical development firm committed to humanizing healthcare and life sciences through innovative technologies and expert guidance.
Why Work at Alira Health?
We offer a vibrant environment with benefits including professional development, global travel, flexible work programs, and more.
Join Our Team
We are a diverse team of over 800 professionals from more than 30 nationalities, providing innovative solutions to improve patient care. Apply to our open positions or send a spontaneous application.
J-18808-Ljbffr
#J-18808-Ljbffr