Senior Data Manager

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, partners with Sponsors, clinical, and statistics 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 person responsible for the project from the data management perspective.

Role

The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical, and statistics 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 person responsible for the project from the data management perspective.

Key Responsibilities

• Accountable for driving achievements of project milestones from study start-up through to delivery of database.
• Provide Data Management input into the protocol.
• Design the Case Record Form and guide process for CRF approval.
• Define and develop the Data Management Plan, Data Validation Plan, and their annexes (e.g., Reconciliation Plan), with input from the study team.
• Validate the database and computerized checks, including SAS listings or SAS checks.
• For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF.
• For EDC studies, respond promptly to issues identified by the eCRF Helpdesk.
• Prepare CRF completion guidelines.
• Prepare study-specific data-entry guidelines and train data-entry staff.
• Perform term coding for clinical studies, raise manual queries for uncoded terms as required.
• Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage data cleaning including manual checks and Medical Review listings.
• Create and test import programs for electronic data received from external vendors.
• Perform timely data integration of CRF and non-CRF data (data import from external sources).
• Perform reconciliation of external data (e.g., SAE, Central Labs, ECGs, etc.).
• Run and monitor study data progress reports, including query management, and take appropriate actions (e.g., escalation, re-training). Escalate any study issues within the study team.
• Define and execute QC plan, lead and execute database release and freeze activities.
• Lead the DM team, coordinate other DM staff, providing direction on work assignment, scheduling, and prioritization.
• Monitor progress against study project plan and escalate issues as needed.
• Contribute to formal training for new starters.
• Apply document management processes and procedures effectively.
• Follow SOPs and guidance documents, including industry standards like ICH, GCP.
• Recommend process improvements and develop new standards.
• Develop and maintain contacts within the study team.
• Maintain communication with the sponsor, sharing critical and general issues.
• Represent Data Management in meetings (e.g., Investigator’s Meetings).
• Perform other activities as required.

Desired Qualifications & Experience

• Degree in life sciences, pharmacy, biology, or related field, or at least 3 years’ experience in data management within a pharmaceutical environment.
• Knowledge of Data Management processes.
• Knowledge of industry guidelines like ICH, GCP.
• Knowledge of coding dictionaries such as MedDRA and WHO-DD.
• Experience with one or more DM systems.

Technical Skills & Soft Skills

• MS Office Suite proficiency.
• 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 (BS) in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular

Alira Health is a global advisory firm providing consulting, research, and clinical development services, aiming to humanize healthcare and life sciences through innovative technologies and expert guidance.

Why Work at Alira Health?

Our global offices foster a vibrant environment with benefits including professional development, travel, flexible work, and more. We value passion, talent, entrepreneurial spirit, service, and teamwork.

Join Our Team

We are a diverse team of over 800 professionals from more than 30 nationalities, dedicated to delivering innovative solutions that improve patient care. Introduce yourself to our recruiters by applying or sending a spontaneous application.

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