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Data Management

Location:
Tucson, Arizona, United States
Posted:
November 30, 2017

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Olusegun(Victor) Adegoke

*** * ******* ****** *****, Oro Valley, Arizona.

Mobile: 520-***-**** ac3jtv@r.postjobfree.com

EDUCATION AND TRAINING

Msc Management Science, University of Hertfordshire, Hatfield, United Kingdom

BTech. Pure and Applied Chemistry, Ladoke Akintola University of Technology, Ogbomosho, Nigeria.

THERAPEUTIC EXPERIENCE

Phase 1-3

Oncology: Brain, Melanoma, Triple Negative Breast Cancer, Lung, Kidney, Prostrate, Ovarian Renal Cell Carcinoma Cancer

Circulatory: Hypertension

Central Nervous System: Multiple Sclerosis

Ophthalmology

Cardiovascular

PROFESSIONAL CLINICAL TRIAL/COMPANION DIAGNOSTIC EXPERIENCE

Senior Lead Data Manager (Permanent) – Roche Tissue Diagnostic formerly Ventana Medical System, Location: Tucson, Arizona July 2016 –Nov 2017

Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for clinical data management issues for the study team.

Uses knowledge of clinical data management to define data flow for assigned projects. Identifies and implements updates to study-specific processes as needed.

Creates or oversees creation of data management documentation for assigned projects, including the Case Report Form (CRF), Data Management Plan (DMP), and clinical database specifications. Maintains robust documentation to ensure and/or document regulatory compliance always. Identifies and implements updates to documentation as needed.

Uses knowledge of database management to define clinical database requirements. Performs user acceptance testing of clinical database and edit checks.

Provides study-specific data entry training to data entry staff. Oversees data entry staff to ensure data quality.

Develop and maintain project plans to include Data Management Plans, Communication Plans, AE Reconciliation Plan

Review and approve project plans and guidelines for data validation, Coding, eCRF screens, database design, collation list, user testing, CRF tracking, eCRF completion

Performs clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data and uses discretion to resolve issues. Identifies and manages data trends.

Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team. Uses professional judgment to escalate issues appropriately.

Provide training for CRA’s and Site staff on EDC system

Review and approve specifications for listings; review and approve output from listings

Updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study.

Performs IxRS, Lab, AE and PD reconciliation.

Generates annotated CRF and other study documentation and file in the DM Binders

Maintains proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data management practices by reading related literature, attending training classes and professional meetings, and participating in project-specific training.

Work with project leader/managers Data management budgeting, forecasting and reporting.

Works closely with IVRS, biomarker labs, and pharma partners in companion diagnostics.

Uses Medrio EDC for Interlaboratory Reproducibility studies.

Uses Tableau for data visualization and reporting, supports Marketing, Clinical Operation, management as needed for data visualization reporting and review.

Senior Clinical Data Manager /Data Standard Committee Member (Permanent) – Roche Product, Location: Welwyn Garden City, United Kingdom Sept 2007-July 2016

Core member of Study Management Team serving as the data acquisition specialist contact at the study and/or program level, providing expert guidance to program teams

Worked closely with CDM study team and maintain oversight of all non eCRF study start-up, study conduct and study close-out data management issues, activities and deliverables

Interact regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provide technical coaching and mentoring on data management activities to colleagues

Contribute to CRO, specialty and Central Lab selections.

Perform RFP, RFI and contract review.

Creation of Data Review plan and Data Quality Guidelines

Lead the development of non eCRF database development and testing specifications by interacting with other functional area representatives such as the clinical programmer.

Responsible for the implementation of standards within Data Management across one or more CDM study teams.

Loading non eCRF data and checking using scripts programs developed in SAS

Develop and execute ad hoc database queries utilizing data review and query tools

Expert data reviewer using Spotfire.

Manage projects resourced externally via contract research organizations or corporate partners

Create data format specification document for Holter ECGs, IVRS, Safeties, PK, PD and questionnaire.

Participate in departmental discussion groups, formal working groups or special projects.

Acquiring and storing of electronic data into RAVE EDC database using tools and servers such as UNIX, RAVE architect, Batch Uploader, Lab Admin Module.

Maintain RAVE Lab Admin Module including definitions, unit conversion (conventional to SI) and maintenance of lab parameters and associated reference ranges.

Reviewing medical imaging contracts-transmission schedules cost and time.

Liaison with Imaging CROs and Imaging Centers, (Universities and hospitals).

Responsible for DM component of eTMF and physical binders

Data Standard Committee tasks:

Defining and maintaining lab metadata SDTM codes.

Researching CDISC SDTM to ensure new tests requested by internal stakeholders/CRO are in line with CDISC standard.

Attend Subject Matter Expert meetings (cross-functional) ensuring systems and metadata align to CDISC and Roche Standards.

Quality Assurance Analyst (Contract) GLP/GMP GlaxoSmithKline, Location: Ware, United Kingdom

Nov 2005-Mar 2007

Data/document review and sample & batch tracking using LIMS, SAP/R3.

Used HPLC/Karl Fischer/UV/pH meter/IR spec/ micro-balance for drug analysis.

Trend analysis and presentation of findings.

Part of a team that implemented CAPA and analyzed root causes.

Other employment

Antimicrobial Analyst Sep 2004- Oct 2005 Laboratory for Government Chemist, Location: UK

Clinical Data processor (contract) Jan 2004 - Jul 2004 Quest Diagnostics, Location: UK

COMPUTER EXPERIENCE

Medidata Rave, Medrio, Spotfire, Tableau, JIRA, BOX, Agile, Schematic Manager, SharePoint, Touchpoint, CTMS Ultra Edit/Compare, Valicert, Safelink.

Tableau training Beginner to Advance

General: Windows, MS Word, Excel, Power Point, MS Project, Smart Sheet, Ganter

Roche Data Management – Strategic and initiative projects

Clinical Data Management projects 2011 - 2017

China Biomarker sourcing project 2013-2014 (Data Management Team Leader).

Cross functional collaboration, Feb 2014. (Project Leader).

Preferred Provider Initiative 2012. (Key Contributor).

Data Management tasks off shore to TCS India 2011-2015 (Subject Matter Expert).

Offsite meeting planner for Biometric team (Spend and Budget manager).

Central Lab collaboration 2014-2016 (Project lead).

Modernizing data reporting using visualization tool Tableau (July 2016-Nov 2017).

Roche Tissue Diagnostics standards committee (SDTM/CDISC) (July 2016-Nov 2017).

China Biomarker sourcing project (2013-2014)

Lead coordinator for the data management section. Organized RFI meetings, offered expert advice to the project team why a CRO should not be considered as a partner based on quality, communication, tools, time and cost.

Roche Tissue Diagnostics standards committee (July2016-Nov 2017)

Led data management effort to standardize variables to SDTM/CDISC.

Attended data standard committee meetings weekly.

Used Schematic manager tool to approve variables agreed in data committee meeting.

Preferred Provider Initiative (2011) and Central Lab Collaboration (2014-2016)

Key contributor to the reviewing and rating of labs, specialty providers and CROs.

Ensured central labs delivered high quality and trusted data to Roche.

Site visit to central labs, reviewed central lab data management processes, built relationships

Modernizing data reporting using visualization tool Tableau (July 2016-Nov 2017)

Created data reporting templates, represented Ventana at Tableau conference Oct 2017, and presented the new reporting method at senior management meeting to an audience of over 70. Trained colleagues on how to use the tool.

Data management off shoring to TCS India (2011-2015) Strategic Partnership

Supported Data Management sourcing to India by designing and delivering a suite of training tools and process documentation to ensure new data managers based in India were appropriately skilled to deliver pRED studies to all required methods and standards.

Managed DM study assignments, process improvement, KPI and quality management.

21 CFR Part 11 presentation (2017)

Created and presented 21 CFR part 11 to the entire Data management and Biostatistician team.

Presentation/Training skills

A confident presenter who has successfully showcased Data Management projects to strategic stakeholders including clinical scientists, imaging scientists, CRO/Lab partners, biomarker leaders and technology managers using video conferencing, face to face and larger audience meeting forum. Led a two-week face to face meeting training colleagues from India on pRED data management processes, on-hand practical use of RAVE/Spotfire, and running Q & A sessions.



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