Data Manager (Expert in Programming & developing EDC systems)

The Data Manager within the ERGOMED Data Management (DM) is responsible for database testing, query management, management of lab reference ranges, serious adverse event reconciliation, vendor data reconciliation and other tasks related to data management. The Data Manager represents a position under direction of the Manager, Data Management and is supervised by the Project Data Manager on a project level.

The Data Manager is responsible for supporting various data management and EDC activities from initiation of protocol through database lock data cleaning activities including:

Study start-up

• Perform validation of EDC Systems and associated DM reports or listings
• Perform validation of EDC and SAS edit checks
• Manage and Create EDC user accounts
• Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
• Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development

Study Conduct (Support multiple moderate complexity / complex trials with minimal supervision)

• May enter Data from trial documents into data entry system
• May perform Medical Coding
• Manage the entry, review, and tracking of Local/Central Lab reference ranges
• Attend internal/external teleconferences as needed
• May create and review study metric reports for internal/external project teams
• Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
• Provide the PDM with status updates on tasks that are assigned
• Escalates significant issues promptly to the study team

Study Closure

• Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports)

Bachelor's Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline

• 4-8 years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.