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The Job
Back ground
The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical
Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. OUCRU-Nepal is hosted by the Patan Academy of Health Sciences, and in Indonesia we exist in partnership with the Eijkman Institute as the Eijkman-Oxford Clinical Research Programme (EOCRU). As a Wellcome Trust Africa Asia Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991. OUCRU's vision is to have local, regional and global impact on health by leading a locally
driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care throughout Southeast Asia. OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil. Please see more information on OUCRU Website: [protected info]
The IT and Data Management group is a functional department that provides IT and Data Management related services to the whole Unit's operation. That includes a professional team to provide IT professional services and Data Management best practices.
Hours of work :Full time
Tenure: Initial for 1 year, include of 2-month probation with possibility for extension.
Reporting to: Lead Data Manager/Head of IT and Data Management
Deadline for submission: 22nd April 2022
JOB SUMMARY
The Data Manager is a member of the Data Management team responsible for the gathering requirement, design, construction, integration, testing, verification and maintenance of required clinical data management system (CDMS) platforms including CliRes (in-house web-based applications for clinical trials) and RedCAP.The Data Manager will provide specialized knowledge and detailed attention to lead and carry out data management and data review activities in support of one or more clinical research studies.
KEY RESPONSIBILITIES AND TASKS
Software Development
- Develop software according to functional and technical design specifications and maintain a "common sense" approach that serves to recognize potential design gaps and provide insight into closing them.
- Create efficient, scalable, reusable middle tier logic using any of ASP.NET, VB.NET,Classic ASP, XML, C#, PHP and other languages as needed.
- Create intuitive, logical and dynamic user interfaces using HTML, HTML5, JavaScript,XSL, EXTJS and AJAX.
- Create and design databases, views, stored procedures, T-SQL statements and user- defined functions of varying complexity with a "best practices" approach to keys,indices and relationships in SQL Server 2008/2012. Experience using typed-datasets is critical.
- Manage Windows 2008/2012 Server, IIS, COM+ and SQL Server with regards to administration and performance tuning.
- Assist in continual improvement of software configuration management process.
Data Manager for clinical trial projects
- Responsible for studying and applying data management platforms that OUCRU have involved with collaborators in differentprojects.
- Working within study teams as an extended team member to define project timelines in the execution of clinical data management operations.
- Collaborates with peers within and outside the organization to pro-actively manage data availability and integration.
- Conducts their work activities in compliance with all relevant regulations, ICH, and CFR guidelines as well as all OUCRU policies and SOPS.
- Responsible for the role which includes executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams.
- Conduct training of study site personnel in eCRF completion, and data clarification processes.
- Coordination of Data Management Data Review activities and ensuring completion of all activities leading to the Study DatabaseLock.
- Responsible for the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan.
- Initiate and manages the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.
- Assist with the clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards.
- Responsible for the representation of the clinical data management & programming organization in one or more clinical studies.
- Responsible for the implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks.
- Delivers training to clinical data management and other departments, as necessary.
Your Skills and Experience
- BSc in computer science, computer engineering, information system or biostatistics
- Strong knowledge and experience in clinical data management, Good Clinical Practice,CFR 21 Part 11, Good Clinical Data Management Practice.
- Having programming experience in C#, ASP.Net or .NET Core, JavaScript, PHP or other equivalent programming languages.
- Having database experience in MS SQL Server, MySQL, MS Access, and PostgreSQL.
- Experience in HTML5, CSS3, DOM, UI frameworks & libs (Bootstrap, Material ...) is a plus
- Be able to understand and writing: SRS, SDD is an advantage
- Strong motivation to apply software development in clinical research
- Analytical problem-solving skills, willingness to learn, self-initiative, attention to detail
- Team player, organized, patient, dedicated, tactful, understanding, disciplined and mature
- Keen on self-development
- English communication or IELTS equivalent 5.5
Why You'll Love Working Here
- Contracted salary: Negotiable (depending on actual experience and education).
- Optional insurance: In-patient and out-patient medical coverage; Personal accident insurance coverage
- Two months' salary for annual bonus and clothes
- Annual leave 18 days each year for the first year
- Other responsibilities and benefits are based on Viet Nam Labour Law.
