✅ Valid work permit in Germany
Results-driven Clinical Data Management professional with over 6 years of experience delivering Phase I–IV clinical trials within global CRO environments. Proven track record managing end-to-end clinical data operations, ensuring accuracy, compliance, and timely delivery across therapeutic areas including oncology, neurology, and GI. Experienced in building strong cross-functional collaborations with CRAs, biostatisticians, medical monitors, and external vendors. Adept in EDC platforms like Medidata Rave and Oracle Inform, with deep working knowledge of regulatory standards including ICH-GCP, FDA, and CDISC. Passionate about data integrity, patient-centricity, and operational efficiency in clinical research. Seeking Clinical Data Manager opportunities in Germany/EU.
CDM Skills: Oncology (RECIST), SAE Reconciliation, Edit Check Specifications, Validating eCRFs, Understanding of Protocol and study schema, Vendor Reconciliation, UAT, Quality review, Rave reporter, SAS check review, Project management, Conduct & Close out phase review,
EDC Platforms: Medidata Rave, Oracle Inform, iMedidata,
Interpersonal Skills: Strong organizational, analytical, and problem-solving skills,Effective communicator and collaborator in fast-paced, cross-functional environments.
Therapeutic Areas: Neurology, Inflammatory, Oncology, Degenerative,
Visualization tools: Excel, Power BI,
Certifications: Agile Project Management, Jira
Animal Welfare Volunteer: Stray dog sterilization, abandoned animal rescue, Reading non-fiction, Hiking, Fitness, Travel