Clinical Data Management Expert
3 weken geleden
Allucent is a biopharmaceutical company dedicated to helping small-medium companies efficiently navigate the complex world of clinical trials. We are committed to bringing life-changing therapies to patients in need across the globe.
As a Clinical Data Management Expert at Allucent, you will play a vital role in leading and overseeing data management activities, timelines, and finances for our Data Management department. Your primary responsibility will be to manage and coordinate DM deliverables from database design and setup to cleaning and reporting, ensuring that clinical data meets quality standards and regulatory requirements.
Your key tasks will include:
- Leading and serving as the primary contact for DM with all relevant parties both internally and externally
- Coordinating the Biometrics project team to ensure project delivery according to planned scope and timelines
- Creating and executing project management plans required for project delivery and established processes
- Establishing project-specific training plans for internal team members
- Establishing clear communication lines and escalation pathways
- Providing support for vendor identification, qualification, and selection, and managing vendors
- Managing study budgets, evaluating financial project health, and managing monthly status updates for invoicing
- Proactively recognizing and addressing any changes in scope and liaising to execute contract amendments
Requirements
To be successful, you will possess:
- A life science or healthcare degree, or a combination of education and experience
- Minimum 8 years of relevant work experience in Clinical Data Management or related experience within Biometrics
- Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements
- Good understanding of Medical Terminology
- Experience as DM Lead on several studies and experience in covering all phases of a clinical study
- Thorough understanding of relational database components and technical data management practices
- Experienced in CDISC conventions and hands-on experience implementing these models
- Client management experience
- Strong written and verbal communication skills, including good command of English language
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
Salary: $120,000 - $150,000 per year
Location: Global Offices
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