Data Management Clinical
Resume:
Micheal Maduka CCDM
CLINICAL DATA MANAGER (LEAD)
*********@*****.***
PROFESSIONAL SUMMARY
Solid record of initiative in assuming new responsibilities, and ability to work in a multifunctional environment. With exceptional skills in Data Management over 7+ years. I have significant experience in EDC, Vendor management, CRO management, query resolution, worked on different therapeutic areas and Customer Service Functions. Highly motivated and goal-oriented individual with a strong work ethic and a creative patient-driven mindset.
Therapeutic Experience
Oncology, Cardiovascular, Respiratory, immunology, Ophthalmology, CNS
Respiratory, Medical Devices.
EDUCATION
Nnamdi Azikiwe University Nigeria June 1996- September 2000
B.sc Management and Economics
CERTIFICATION
Certifier Clinical Data Manager
AWS Cloud Architect and Devops training
OSHA compliance, CPR, H2S training
Relevant Skills
Guidelines for Good Clinical Practices and the Code of Federal Regulations/ICH Guidelines
Compared listing with the CRF data, marking any differences that are not accounted for by data entry instructions.
Patients advocate, & trained mental health specialist
SAE reconciliation Quality Control. (QC)
Database cleaning and discrepancy management.
Generated and designed DCF for data clarification.
Data validation and verification.
CRF review and tracking
Dictionary coding MEDRA, Working on phases I, II and III clinical trials.
Query Generation/Discrepancy Resolution
Data retrieval/Data Listings, SAE Reconciliation
Experience using OC-RDC, Medidata Rave Inform, Microsoft Office (Word, Excel, Access, PowerPoint) in-house query and tracking systems.
Ensured communication, co-ordination, and collaboration among Data Management staff, with other groups in the department and other departments in a global environment.
Responsibilities
Key point of contact for the sponsor and the trial team on all trial data management activities
• Create and adhere to timelines in the implementation of trial tasks, ensure all work performed is of high quality, compliant with Good Clinical Practice (GCP), ICH Guidelines and all applicable laws and regulations
• Proficient with Electronic Data Capture (EDC) systems, such as Medidata Rave and Oracle Inform. Able to adapt knowledge to other EDC platforms as needed
• Read and understand each assigned oncology protocol
• Develop project specific clinical database specification as needed. Work with Database Programmer, Project Manager, and Sponsor on creation of unusual and dynamic database forms. Participate in and ensure a quality database design.
• Lead the development of Data Validation Specifications (DVS) for robust edit check programming and testing of the clinical database
• Perform User Acceptance Testing (UAT) including validating data entry screens and testing edit checks. Report errors to the database programmer and assist them in making appropriate corrections.
• Generate data management documents appropriate for the clinical trial, including but not limited to the Case Report Form (CRF), Data Management Plan (DMP), CRF Completion Guidelines (CCG), Data Review Quality Specification (DRQS) and Data Validation Specification (DVS)
• Work with the Sponsor and third-party vendors to create Data Transfer Specifications (DTS) for transfer of external data
• Perform data reconciliation, including adverse event (AE), serious adverse event (SAE) and external lab data reconciliation
• Develop and generate data reports from EDC systems which detail the progress of the trial and help in identifying trial related data issues and report trends
• Develop and generate data reports from EDC systems for medical meetings such as safety review meetings and dose escalation meetings. This includes generating patient profile reports and aggregate data listings.
• Perform medical coding of terms and medications using medical dictionaries such as WHO Drug and MedDRA
• Ensure Sponsors understand the medical dictionary licensing process for each trial
• Work with clinical trial site staff, investigators, and Clinical Research Associates on review of the trial database entries, data query and query resolution
TRANSLATIONAL DRUG DEVELOPMENT CONFIDENTIAL © 2022
• Ensure clean and valid clinical trial data for delivery to biostatistics through involvement in all phases of global clinical trial data management process from trial start up to database lock.
• Delegate tasks, monitor performance, and provide mentorship, training and guidance to the Clinical Data Associate(s).
• Work with the assigned Clinical Data Associate(s) to perform delegated DM tasks.
• Generate trial metrics as needed for financial revenue recognition.
• Prepare, review and submit appropriate data management documents for upload to the Trial Master File.
• Train appropriate team members on data management activities and participate in the creation and/or revision of department training material.
• Perform other related duties as assigned
Professional Experience
TD2 Translational Drug Development January 2023 - Present
Clinical Data Manager (Lead)
Glaukos Cooperation: May 2020 – January 2023
Lead Clinical Data Manager
Siemens Healthineers: March 2018 – May 2020
Clinical Data Manager.
Health Core INC May 2017- March 2018
New Jersey
EPIC Sept 2015 – May 2017 Virtua Health, Columbus, South Jersey
SYSTEMS EXPERIENCE
Windows, Word, Excel, Access, Power Point, Outlook, Oracle Clinical, JReview Medidata Rave, OCRDC. Inform, iMednet, Teams, SharePoint, MedDRA, WHODRUG Windows NT 4.0/2000, Open Clinica, Pierce EDC, Veeva Vault
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