Nusrat K Dean
Waldshut-Tiengen
Summary
✅ Valid work permit in Germany/EU
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
8
8
years of professional experience
1
1
Certification
Work History
University Student of Public Health
University of East London, UEL
01.2023 - 02.2024
- Gained in-depth knowledge of epidemiology, biostatistics, health policy, and environmental health.
- Conducted research on public health trends and contributed to health data analysis projects.
- Developed skills in program planning, monitoring & evaluation, and health promotion strategies.
- Worked on case studies involving disease prevention, global health, and community health interventions.
- Strengthened ability to interpret health data and apply evidence-based practices in real-world settings.
Senior Clinical Data Manager
Fortrea (Formerly Labcorp)
01.2020 - 11.2022
- Oversaw end-to-end data management activities for multiple global clinical trials using Medidata Rave.
- Successfully completed projects of Oncology: Tumor finding (Phase 1,2 and 4), Hodgkin's disease-Lymphoma (Phase 2), Mesothelioma and Melanoma including uveal melanoma (Phase 1), Gastric Cancer (Phase 2a) using Medidata Rave.
- Gathered content and integration requirements for eCRF and other data collection tools. Provided clear guidance within the eCRF for site staff to ensure accuracy at the point of data entry.
- Developed and executed Data Management Plans (DMPs), edit check specifications, and UAT. Created, planned, and tracked content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival under minimal supervision.
- Created clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
- Performed trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML direction.
- Prepared reports and presentations to update stakeholders on trial progress and data status.
- 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.
- Lead the trial projects successfully, established, aligned and ensured data management expectations with trial stakeholders. Mentored junior CDM staff and provided backup support to Principal Clinical Data Leads.
- Provided oversight on SAE, local lab, and imaging data; supported regulatory submissions.
- 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.
- Reviewed CRFs to ensure completeness, accuracy, and compliance with study protocols.
- Managed the freezing and unfreezing of clinical trial data forms ranging from 20-300.
- Supported the filing of eTMF documentation to maintain an inspection ready environment throughout the study lifecycle.
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 Science - LifeSciences
Mount Carmel College
Bangalore06-2013
Bachelor of Science - LifeSciences/ Biochemistry
Sophia College
Mumbai 06-2011
Core Competencies
- Clinical Data Management(CDM): Over 6 years of experience as a Clinical Data Manager supporting Phase I–III trials
- Oncology Expertise: Significant exposure to oncology trials including (Tumor finding (Phase 1,2 and 4), Hodgkin's disease-Lymphoma (Phase 2), Mesothelioma and Melanoma including uveal melanoma (Phase 1), Gastric Cancer (Phase 2a).
- EDC Platforms: Proficient in Medidata Rave, Inform, Oracle Clinical, and Veeva Vault EDC for study build, data cleaning, and database lock activities.
- Project Management: Certified PMP experienced in managing cross functional timelines and deliverables.
- CRO experience: Worked with global CROs and pharmaceutical clients such as IQVIA and FORTREA with 6 years of experience in a CRO environment, managing multiple concurrent studies.
- Lead Role : Successfully contributed to projects as a Team Lead, adapting quickly to new protocols and tools while ensuring high data quality and compliance with ICH-GCP and CDISC standards.
- Communication skills: Strong interpersonal skills. Experienced in collaborating with cross-functional global teams, external vendors, and sponsors to deliver high-quality, inspection-ready data.
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, Cardiology
Visualization tools: Excel, Power BI,
Certifications
PMP : Certified Project Management Professional.
Agile Project Management, Jira
Volunteerism and Interests
Animal Welfare Volunteer: Stray dog sterilization, abandoned animal rescue, Reading non-fiction, Hiking, Fitness, Travel
Timeline
University Student of Public Health
University of East London, UEL
01.2023 - 02.2024
Senior Clinical Data Manager
Fortrea (Formerly Labcorp)
01.2020 - 11.2022
Clinical Data Manager
IQVIA
03.2016 - 03.2019
Master of Science - LifeSciences
Mount Carmel College
Bachelor of Science - LifeSciences/ Biochemistry
Sophia College
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