Meet the Team
Amanda Bravery (Head of ICT, ICTU)
As Head of ICT, ICTU, Amanda Bravery leads the Clinical Data Systems team; a multi-disciplinary team of Developers, Testers and Production Support staff, who work collaboratively with Investigators and Researchers to provide an electronic data capture system in line with the study protocol and regulatory standards. The team successfully supports many Imperial College Investigators and Clinical study teams with a comprehensive service to facilitate easy, fast and accurate data collection, management and analysis through electronic data systems.
Training
Vacancy (Data Systems Officer)
This role is mainly service based and covers a wide range such as user management, user and incident support; along with releasing studies to the test server for User Acceptance Testing (UAT); and releasing EDC studies to live environment. The DSO will help our EDC user base with training needs and guidance.
The DSO will help to archive the study database documentation after the study database has been locked; and documents, reviews and updates production support processes, identifying best practices and suggesting improvements to current ones.
Systems Development team
The Development Team consists of Data Specialists who use customers’ requirements to design, develop, test and document eCRFs for a wide variety of trials and therapeutic areas. In addition, the Systems Development Team is responsible for writing validation rules and liaising with the testing team through the various testing and user acceptance cycles.
Abinithya Udayakumaran (Systems Development Manager)
Abi is the Systems Development Manager for the CDS team. She has several years of experience within the clinical industry as trial lead/database developer and reports developer. She has knowledge in EDC (Electronic Data Capture) and eCOA (Electronic Clinical Outcome Assessment) systems. She has worked across several therapeutic area studies. As Systems Development Manager, she is responsible for the leadership and management of the Systems Development Team with the aim of delivering high quality eCRFs for healthcare related trials through the lifecycle of design, development and unit testing. She is also responsible for ensuring that the solutions delivered are both fit for purpose and compliant with regulatory requirements and delivered within strict timelines.
Smita Das (Data Specialist)
Smita is a Data Specialist. She is responsible for designing, developing, unit testing, documentation and other validations required for eCRFs. Smita is also responsible for writing validation rules and guiding the testing team during various stages of the testing of clinical trials.
Zala Noorzad (Data Specialist)
Zala is responsible for designing, developing, unit testing, documentation and other validations required for eCRFs. She has previous experience working in clinical trials, including performing site data management, operational responsibilities and designing source documents for early phase cancer trials.
Production Support team
Nayan Das (Data Systems Manager)
Nayan is the ICTU Data Systems Manager for the EDC systems. He has experience developing within the Oracle Applications Enterprise framework, after which he has successfully transitioned into the development and delivery of EDC systems. Nayan has subsequently moved into Data Systems to provide user support to all CDS study teams. Nayan's role involves investigating any reported issues and liaising with various internal/external colleagues to gain a resolution. Another key area of his role is the loading/extracting of study data. Nayan has been heavily involved in the CSV activities in these areas, in addition to the more regular validation activities associated with maintaining a production environment.
Stefan Sprinckmöller (Senior Data Specialist)
Stefan has over eight years’ experience in data management, project management, and mix-methods research, leading health data-driven projects, health data and research. He has worked in several clinical trials and studies in the United States and United Kingdom.
Stefan's Senior Data Specialist role is mainly service based and covers a wide range such as releasing trials to the test server for User Acceptance Testing (UAT); delivery of EDC trials in liaison with the ICT Change team; user support; incident, capacity and availability management. Other projects entail prototyping EDC functionality to be used in the running of the Clinical Trial Portfolios supported by the team.
Validation and Test team
Francesco Lala (Deputy Head of Clinical Data Systems)
Francesco has over ten years’ experience in Clinical Trial Research. He has worked in multi-disciplinary international clinical trials and research including setting up Phase I/II clinical trials across different countries. Over the last few years his focus has been on validating computerised systems for GCP use and implementing tools for quality data collection.
Dinesh Sivakumar (Senior Data Specialist)
Dinesh has an academic and research background and holds a PhD in General Anaesthesia research. He is also an ISTQB BCS Certified tester with several years’ experience in testing and validating electronic data capture systems used for clinical research. Dinesh provides validation support throughout the software development lifecycle and in line with relevant regulatory guidelines.
As a Senior Data Specialist, Dinesh is responsible for the validation of systems used for Good Clinical Practice and bespoke trial designs in electronic data capture systems including InForm, Oracle Health Science and OpenClinica.
Adina Ion (Data Specialist)
Adina is a Data Specialist who is predominately involved in the validation and testing of electronic data capture systems used for clinical research. She authors test scripts and executes tests working closely with the validation test lead, eCRF testers, eCRF developers and senior management.
Adina has a strong background in medical technology and she is an ISTQB-BCS Certified Tester with experience in highly regulated industries.
Tolulope Sokunle (Data Specialist)
Tolulope is a validation and system test analyst with years of experiences within the financial and IT sectors.
She is presently involved with all testing processes within CDS but deals predominantly with the validation and testing of eCRFs adopted for use in clinical trials, using InForm, oracle based software and OpenClinica.
Tolulope has a degree in mechanical engineering.
Data Management
Vivienne Okona-Mensah (Senior Data Manager)
Vivienne is the ICTU Senior Data Manager. Her role involves identifying, devising, and implementing data management processes required within the department, she works closely with the Clinical Operations team, Statisticians and ICTU Team Leaders.
She is a skilled clinical data management professional with a wealth of experience working on clinical trials spanning numerous therapeutic areas and phases having worked in the pharmaceutical industry and NHS/Private healthcare settings.
Safa Anwar (Data Manager)
Safa is the ICTU Data Manager. Her role is a hybrid one, working as Data Manager for both the CDS and ICTU global teams. She is involved in all data management tasks throughout the lifetime of a trial incluing the production of relevant documents, as well as the collection, storage, preparation for evaluation, extraction and archiving of data collected.
Safa utilises her breadth of experience in bioinformatics and computing, applying these skills into a clinical environment to further a new era of clinical trials.