Project Data Manager

Summary

Join Ergomed Group, a thriving CRO specializing in Oncology and Rare Disease, as a Project Data Manager. You will independently lead and manage multiple data management projects, ensuring timely completion within budget and quality standards. Responsibilities include overseeing database builds, conducting audits, managing escalations, and collaborating with internal and external teams. The ideal candidate possesses 5-8 years of data management experience in the pharmaceutical or biotech industry, proficiency in EDC systems, and strong computer skills. Ergomed offers training, career development, a supportive work environment, and opportunities for global collaboration. Our core values emphasize quality, integrity, drive, agility, belonging, and collaborative partnerships.

Requirements

• 5 – 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

Responsibilities

• 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 finalization, eTMF filing, data cleaning and reconciliation, as required

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language