Data Manager at Medical Research Council

Location: Faraja, Gambia
Duration: The appointment is up to 2 years and is subject to a probationary period of 6 months.
Grade: 3, 28 Points

Job Description

• Data management is a vital component of the scientific discovery process, and the unit views data management accordingly. With the advancement of technology, data management has become the epicentre for successful organisations due to the critical role it plays in business intelligence, informing of policies, and much more.

Purpose of Job

• The post-holder will be based at MRC Fajara and S/he will be responsible for all data management aspects of the project according to the Unit’s data management procedures.
• The post-holder will be working closely with both programme-based staff and data management staff. S/he will develop, organise and implement quality control and cleaning processes of the project database for use in all four settings requiring extensive liaison and tactful communication with field personnel as well as other project staff.
• The post-holder will work with the project staff to design data collection tools, monitor the quality of collected data, and organise the data management process. This will involve responsibility for the development, testing and passing as fit for purpose of study data collection instruments. These will include version control implementation.
• The post-holder will oversee the distribution, reception, storage and retrieval of data collection instruments, and all aspects of data management of the programme. S/he will work with project staff to ensure that the data are of high quality and are processed in a timely fashion.
• The post-holder will also work with Data Supervisors to agree on scheduling of data entry and verification / data downloads and verification.
• A good understanding of study procedures and field work is needed. Close attention to detail and efficient organisation will be required to monitor the cleaning process and follow all queries through to resolution or to designation as insoluble. This work will include involvement in the development and adherence to SOPs used by the Unit for data management procedures.

Role
Study Documentation Development:

• Design, review, develop, maintain and update relevant CRFs, and study specific procedures (SSPs), keeping appropriate version control.
• Ensure all study documentation are in order and filed in a Project Master File (PMF) as per the department’s SOPs.
• Provide input during the design stage of CRFs (paper/electronic) with emphasis on the unit’s data coding standards.
• Advice on CRF design format with emphasis on logic of questions and ease of data processing.
• Development of the study Data Management Plan (DMP), maintenance of DMP throughout lifecycle of the study and ensures DMP is followed according to study design and requirements.

Database Work:

• In collaboration with the database developers create OpenClinica, REDCap, SQL server and/or Microsoft Access databases.
• Be responsible for data quality, by checking for validation and inconsistencies, raising and resolving of queries with the study team and keeping track of any paper audit trails.
• Be responsible for extracting and querying data from any of the above systems.
• Update CRFs and the related databases and variable lists (data dictionaries) when any modifications are made to data collection processes including version control procedures.
• Prepare statistical data summaries.
• Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, and final database lock.
• Be responsible for completing all relevant and required metadata for all datasets generated and submit to the electronic data repository for archival.

Management and Training of Staff:

• Manage the printing of all study forms and their distribution to the relevant staff.
• Issue follow-up schedules for field teams, for longitudinal studies, ensuring all forms are returned for processing and produce summary descriptions of data on request and at meetings to see the trend in the study.
• Monitor the quality of work performed by each member of the team dealing with forms/data using the audit routines and performance report of data system (to be developed by the database developer) and resolve any problems of staff performance that are identified.
• Monitor the error rate of form completion by field workers and liaise with senior staff to resolve any problems that are identified.
• Training for data collection (eCRF & pCRF) and data entry staff and bespoke training for scientific staff.

Trial data Compliance:

• Assist PI’s in preparing reports for the Trial Monitors, ensuring that the forms requested are available on time, and are refilled properly following the completion of monitoring.
• Monitor all forms of data collection.
• Collaboration with clinical and laboratory staff to ensure optimal clinical data collection.
• Ensure all procedures are in accordance with SOPs, Good Clinical Practice, and ICH Guidelines where applicable.

Other:

• Undertake all work strictly following the relevant Safety Rules and Regulations as laid down in the MRC safety Manual

Relationships:

• The post-holder will be a full-time member of the MRC staff.
• The post holder will report to Mr Bai Lamin Dondeh, the Head of Data Management.
• The Unit Director is Professor Umberto D’Alessandro.
• The Director of Operations is Mr Joan Vivestomas.

Appraisal:

• Appraisals are held at least annually.

Any other duties:

• To carry any other duties consistent with the remit and level of the post.

Person Specification
Essential requirements:

• B.Sc or equivalent in data processing, computer science or data management.
• Minimum of 3 years work experience and proficiency in data management - with preference given to data management for medical research
• Previous experience of dealing accurately and efficiently with large volumes of data from varied sources in multidisciplinary research projects.
• Excellent problem solving skills, analytical skills, and judgement
• Working knowledge of Good Clinical Practices (GCP), Clinical Research, Clinical trial process and related regulatory requirements and terminology
• Working knowledge of Clinical database applications
• Excellent written and spoken English
• Experience of training and supervising staff
• Good working knowledge of database management software (MS Access essential and SQL Server preferred).
• Systematic approach and attention to detail.
• The ability to conduct study activities according to the protocols.
• The ability to work co-operatively in a team.
• Understanding of the confidential nature of the work.

Preferred:

• Previous experience working in a research / clinical lab field
• Experience in supporting electronic data capture processes
• Experience in using a Clinical Data Management System.

Salary
The salary will be in grade 3, 28 Points on MRCG at LSHTM pay scale.