Nusrat K Dean
Waldshut-Tiengen
Summary
✅ 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.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Senior Clinical Data Manager
Fortrea (Formerly Labcorp)
01.2020 - 11.2022
- Oversaw end-to-end data management activities for multiple global clinical trials.
- Managed the freezing and unfreezing of clinical trial data forms ranging from 20-300 and Learning Logs (LLs) in accordance with study progress.
- Activated and inactivated forms and LLs as needed, ensuring data integrity and compliance with study protocols.
- Developed and executed Data Management Plans (DMPs), edit check specifications, and UAT.
- Led coordination with third-party vendors for external data setup, import, and reconciliation.
- Issued and closed 50-500or more queries following data management plans, maintaining high-quality, clean data sets.
- Provided ad hoc support to Clinical Research Associates (CRAs) and trial sites, addressing data issues and ensuring smooth trial operations. Ensured compliance with industry standards and maintained audit-ready documentation.
- Provided oversight on SAE, local lab, and imaging data; supported regulatory submissions.
- Mentored junior CDM staff and provided backup support to Principal Clinical Data Leads.
Clinical Data Manager
IQVIA
03.2016 - 03.2019
- Supported eCRF development, data validation, and ongoing cleaning activities.
- Generated metrics, multiple data listings, and tracking reports for study teams and sponsors.
- Executed discrepancy management, SAE reconciliation, and query resolution.
- Contributed to the design and execution of clinical data review plans.
- Ensured compliance with ICH-GCP, regulatory guidelines, and standard operating procedures.
- Supported global clinical trials by ensuring accurate data collection, cleaning, and query management.
Education
Master of Public Health -
University of East London
London02-2024
Master of Science - LifeSciences
Mount Carmel College
Bangalore06-2013
Bachelor of Science - LifeSciences/ Biochemistry
Sophia College
Mumbai06-2011
Certification
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
Volunteerism and Interests
Animal Welfare Volunteer: Stray dog sterilization, abandoned animal rescue, Reading non-fiction, Hiking, Fitness, Travel
Timeline
Senior Clinical Data Manager
Fortrea (Formerly Labcorp)
01.2020 - 11.2022
Clinical Data Manager
IQVIA
03.2016 - 03.2019
Master of Public Health -
University of East London
Master of Science - LifeSciences
Mount Carmel College
Bachelor of Science - LifeSciences/ Biochemistry
Sophia College
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