MRC UNIT, THE GAMBIA Job Description Head of Data Management 1. Job title: Head of Data Management 2. Accountability: The post holder is accountable to the Theme Leader for Disease Control and Elimination 3. Purpose of the Job: The post-holder will be responsible for improving the quality of data management in the Unit by developing and implementing the Unit's data management policy. The postholder will be responsible for developing the Unit's capacity for managing research data to the standard expected of an international clinical trial centre. 4. Introduction: Established in 1947, the Medical Research Council in The Gambia has an international reputation for ground-breaking research into some of the leading causes of morbidity and mortality in the tropics. Achievements include a large trial showing the efficacy of Haemophilus influenzae type B vaccine in The Gambia and the subsequent near elimination of the disease, pioneering studies of the impact of insecticide treated bed nets as a preventive measure against malaria leading up to their worldwide use, studies demonstrating the impact of conjugate pneumococcal vaccines on pneumonia and child mortality and the demonstration of a dramatic reduction in the carriage of Hepatitis B in The Gambia due to the effects of vaccination. To reflect changes in national and global health priorities and new international funding opportunities a new research portfolio is being organized under three themes: Child Survival; Disease Control & Elimination; Vaccination. These themes have been selected to target national health needs, to reinforce sub-regional and international links and to address some of the major current priorities in the Millennium Global Health Goals. The MRC Unit; The Gambia to support its increasing portfolio of grants intends to further strength its capabilities for data management through the appointment of an International Post as Head of Data Management. The Data Management team is a dynamic part of the Unit, and plays a vital part in the successful implementation of studies. The Unit has built up extensive experience in the use of Microsoft products developing solutions using MS Access, MS SQL Server, VBA, VB.Net, C#.Net, ASP and ASP.Net., it has also implemented Open Source Data Management tools such as OpenClinica and the Open Data Kit. Data Management also works alongside the Unit's Statisticians and conducts a great deal of work in close collaboration with the Statisticians. MRC Gambia runs many studies simultaneously. Each study requires its own data management solution. The Unit has an efficient and established a centralised pool of data entry staff funded by projects but which works across all projects. The Unit has a small core team of Database Developer, Data Manager and a Manager of Data Entry which is supplemented by flexible externally funded project staff . The Unit is committed to Good Clinical Practice (GCP) and its requirements, and works steadily to improve its compliance. 5. Grade: Salary will be in Band 3 6. Role: The post-holder will: 1. Be responsible for strengthening the management and quality of data management in all studies. The person will take a lead role in developing robust systems to manage the application production cycle, the study process, and to ensure regulatory requirements are met. 2. Be expected to take a lead role in identifying weaknesses, developing managed solutions, negotiating with senior colleagues, and implementing changes. 3. Be responsible identifying, establishing and implementing new technology strategies as they affect data management at the Unit. 4. Develop and implement the Unit's data management policy, ensuring the Unit's adherence to the Data Protection Act; the principles of Good Research Practice and Good Clinical Practice; and the requirements of the ICH for clinical trials as they relate to data processing and will also monitor and review our adherence to these standards. This will be achieved by: Advising research scientists on the design of databases and the development of data processing plans. Oversee the design, construction and maintenance of relational databases for clinical trials and epidemiological studies for the Unit's research programmes. For complex studies involving field, laboratory and hospital-based data collection this will require detailed analysis of the flow of information, the follow-up of subjects and the processing of samples, the design of forms, the design of single or multiuser databases, the design of data entry forms, checking procedures, and of data queries. Developing and running a formal programme of induction, training and on-the-job supervision to build the capacity of data management staff to query in SQL Server, and to manage study data to a high standard. Establish standard procedures for data management that might include the use of standardized codlings and formats for commonly used variables; the use of encryption and coding algorithms for handling confidential data; the use of check digits for personal identifiers; and the development of a set of standardized questionnaire modules. Be directly responsible for the technical supervision and management of the Unit's database developer, data managers, manager of data entry and provide technical guidance for data supervisors, and the Unit's data entry staff, now housed in a single pool. To establish an annual workforce plan for data management, working closely with scientific staff ensuring that the effective coordination and allocation of staffing meets the priorities and availability of resources within the Unit 7. To undertake any other duties consistent with the remit of the post. 8. Relationships: i) ii) iii) iv) The post-holder will be a full-time member of the MRC staff. The post-holder will report to Professor Umberto D’Alessandro, Theme Leader Disease Control and Elimination The Unit Director is Professor Tumani Corrah. The Director of Operations is Mr Peter Noble. 9. Appraisals: Appraisals are held at least annually. 10. Length of appointment: The appointment is for 3 years and is subject to a probationary period of 6 months. PERSON SPECIFICATION Title: Head of Data Management Essential MSc in an appropriate subject Detailed and broad understanding of managing data in clinical studies. Particular value will be placed on experience that relates to GCP compliant work. You should have experience of quality assurance and control in a clinical data environment. Sound understanding of Microsoft Database solutions – including MS SQL Server, MS Access, IIS and Net technologies. Particular value will be placed on explicit application development experience. Experience designing and managing studies in OpenClinica Significant experience in leading, developing, managing and motivating effective teams Excellent verbal and written English communication skills and the ability to interact with people of diverse cultures and levels A clear vision and capabilities to influence and introduce new technologies for electronic data capture to ensure the Unit meets quality standards and secures value for money. Ability to be self-reliant, self-driven and results oriented Capable of prioritizing and managing his/her time and work load effectively Desirable Experience in programming and implementing mobile devices Experience in a high-level coding language