Context and Role:
The Data Manager (DM) is a member in a NIHR funded stroke project. The DM will be involved in remote data monitoring, conduct site visits, follow up the clinical academic study staff for training and ensure high quality of data collection and audit ready data.
Reporting Relationships: Research Fellow
Duties and Key Responsibilities:
• Assist the Chief Investigator, Trial Manager and Trial Statistician in the ongoing identification of trial-specific data management requirements.
• Co-ordinate regular review of Trial Master File (held at George Institute India) and site files providing quality assurance for regulatory authorities, inspection and audit.
• Support site staff with the implementation, maintenance and usage of trial-specific databases, information systems and services.
• Train and support site staff in the correct procedures for processing and entering data, maintaining accuracy and quality control • Support a process and audit trail for data transfer, ensuring this process is completed in accordance with current data protection legislation and trial procedures
• Quality assure systems for the management, storage and restricted access of data. • Centrally monitor data collected, in collaboration with the Trial Statistician and the Lancashire CTU, and raise any queries identified in a timely fashion. Facilitate the resolution of queries as agreed with Lancashire CTU.
• Conduct regular on-site monitoring to agreed project-specific monitoring plan raising any queries identified in a timely fashion (facilitate the resolution of queries as agreed with Lancashire CTU).
• Prepare a full report within 5 working days of each monitoring visit for review by Lancashire CTU.
• Assist in the preparation of data for interim analyses, presentations and publications as required by Lancashire CTU, Trial Statistician, and Chief Investigators as required.
• Present data updates at specific project meetings as required.
• Contribute to the co-ordination of database close/lock and archiving of relevant study data and information across all sites.
• Maintain confidentiality at all times. • Undertake other duties appropriate to the level of the post as determined by the project.
• Flexible to travel 10% of his time.
Skills, Knowledge and Experience:
• Qualifications: Bachelors or Masters in a related science or health care discipline, clinical data management research background preferred.
• More than 3 years Experience years experience in clinical data mangment within an academic, CRO or pharmaceutical environment.
• Demonstrated capability to produce outcomes and achieve objectives within agreed time periods;
• Strong problem solving, analytical skills, and proven strategic thinking;
• Excellent interpersonal skills with high level of proficiency in English and the ability to work well autonomously;
• Excellent team-work skills, with demonstrated ability to collaborate in small teams and with a wide range of varying stakeholders;
• Ability to demonstrate flexibility and to be adaptable to changing organisational priorities and ambiguous environments;
• Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs;
• Well organised and efficient, with the capacity to work under pressure;
How to apply: Interested candidates should send their applications to firstname.lastname@example.org by 24 September 2018, clearly mentioning 'Data Manager' in the subject line.Your application should include: CV with full contact details of three referees.