Job DescriptionThe Project Data Managers (PDM) within the ERGOMED Data Management (DM) department has full responsibility for the successful planning, execution, monitoring, control, and closure of multiple projects. The Project Data Manager represents a position under the direction of the Manager, Data Management.
- Independently lead and delegate tasks to ensure timely completion of project activities to project timelines, quality, and budget
- Serve as the primary point of contact for internal teams and external vendors
- Conduct internal quarterly audits and ensuring data submission readiness
- Manage escalations and study complexities with confidence
- Work with PMs to review, forecast budget; ensure study demands / hours / cost / deliverables are in line with budget line items
- Provide feedback to other project team members and managers to improve the deliverables
- Monitor project risks and implement mitigation strategies
- Thorough knowledge of the end-to-end reporting process (data management, statistics, medical writing)
- Oversee database build and migration and ensure a quality and timely deliverable
- Work with the Lead Data Manager to access data quality issues and develop plans for interim analysis, DRM, DSMB etc. to key stakeholders
- Drive adherence to data standards and compliance
- Keep abreast of project status and ensure delivery requirements and deadlines are clear and achieved via frequent communication with project teams
- Support DM team with key deliverables including documentation creation, finalization, eTMF filing, data cleaning and reconciliation, as required
Qualifications5 - 8 years' experience in data management at a pharmaceutical, biotech, or research facility.
Experience in working with EDC systems (e.g. Merative Zelta, Medrio, Medidata RAVE)
Proficiency in computer applications: Windows, Excel, Word, Outlook etc.
Additional InformationWhen 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.
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