Data Manager (Expert in Programming & developing EDC systems)

Medicine moves forward here. So will you.

Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.

Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.

The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.

Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.

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

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

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

Responsibilities

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; 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

Requirements

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