Clinical Trials Data Manager (OUCRU)

Background

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 has partnerships with the Patan Academy of Health Sciences and Patan Hospital, and OUCRU Indonesia exists in partnership with the University of Indonesia. 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.

OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.

Please see more information on OUCRU website: www.oucru.org

Job Details

Position: Clinical Trials Data Manager
Department: Clinical Trials Unit
Location: Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam
Hours of work: Full-time. Working hours are 37.5 hours per week.
Tenure: Initially for 1 year, including a 2 month probation period, with possibility of extension.
Reporting to: Head of CTU

Job Summary

The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified clinical research staff to ensure efficient and high-quality research operations in line with international standards. The candidate will join a dynamic group running clinical research. This position will be based at OUCRU HCMC, under supervision of the head of CTU. The post holder will proactively drive quality and efficiency to meet timelines and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the OUCRU programme study teams. The post holder will have a good understanding of how the general concepts underlying the design, conduct and analysis of clinical trials apply to data management and integrity and serve as a technical resource to the study teams for DM standards, tools, data provisioning, and reporting. The post holder will ensure timely and high-quality database design and development including documentation, validation, implementation and monitoring of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.

The post holder will be responsible for the selection and application of data standards, data management plan, selection of quality risk indicators, third party study data due diligence as well as accountability for quality study data set release and consistency in asset/submission data.

Key Responsibilities and Tasks

Key responsibilities include but are not limited to:

Contribute to the development and testing of trial databases and electronic case report forms (eCRFs) for studies.
Working with the study team, review, analyse, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
Support study teams with query management and help to resolve errors and inconsistencies where necessary ensuring that study data is complete, accurate and up to date.
Produce, or assist study teams to produce, regular status reports (e.g. data entry progress, query progress) as required for study team, statisticians, funder(s) and sponsor(s).
Work closely with the study teams to continuously develop and maintain internal data management procedures (including Standard Operating – – Procedures for data provision, eCRF completion guidelines, data manipulation and management, and archiving and destruction of datasets) and ensure all processes are appropriately documented.
Ensure that all programme-wide data management processes such as data sharing are consistent and kept up to date with international and local legal requirements such as GDPR, FDA & ICH, GCP, etc.
Support the study teams to ensure adherence to all data management activities as detailed in internal SOPs or as agreed within study specific plans.
Assist the study teams with delivery of training for staff / sites (database training, CRF completion training).
Undertake other duties as may be required from time to time that are commensurate with the grade and responsibilities of the post.

Selection Criteria

Essential criteria:

A degree or equivalent qualification in a biomedical/scientific/statistical or allied field.
Substantial prior data management experience required.
Experience of working in clinical trials, with a particular experience of working with clinical data.
Knowledge and experience in developing, establishing, managing and maintaining processes and systems for the collection of study/trial data including the entry (good understanding of CRF design and management), processing and validation of such data and its archiving.
An aptitude for large and/or more complex relational database including query/report writing and a full range of data verification, cleaning techniques.
High standards of accuracy and a working knowledge of the international research framework such as EU Clinical Trials Directive, FDA & ICH, GCP, GDPR, Research Governance Framework, and related regulatory requirements.
Excellent verbal and written communication skills with the ability to liaise effectively with different staff and those with different levels of computing experience
Self-motivated and able to work with enthusiasm in an organised manner with minimum supervision.

Preferred criteria:

Previous experience of data management of large-scale datasets, large data in primarycare, and/or other electronic health records
Previous experience of regulatory trial data requirements and management.
Working experience applying CDISC/CDASM/STDN standards
Experience using data visualization tools (e.g. Spotfire, Tableau, jReview)
Familiarity with MedDRA/WHO-Drug dictionaries.
Experience working in LMICs particularly in South East Asia.
Demonstrable programming skills in statistical packages such as Stata, SAS or R

Benefits

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.