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.

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.

Originally posted on Himalayas