1. Profile for assignment 00004753, Clinical Data Managers / Reviewers
Clinical Data Co-ordinator Job Description
Primary Duties:
Co-ordinate the processing of clinical trial data for specified protocols for analysis for Registration
and local studies. Our client is looking for someone who can lead their own studies, someone who
has Project Management knowledge and experience and can drive studies to timelines. This is a
very hands-on data review role. It will involve Project Management driving timelines as appose to
just supervising. The Key aspects of this role would be leading towards a Project Management role,
leading 5 protocols on their own or with assistant; they will be working on any number of therapy
areas on either EDC or EDF systems. They will be working on the entire remit of the data review
function rather than programming or using tools to handle the study. They will be working from
when the 1st patient is recruited all the way through to the database lock.
Summary of Duties:
• Migrate / deliver high quality data for specified protocols within agreed timeframes to achieve
prompt submissions/publication of results
• Write project procedures and guidelines for effective data capture and review in collaboration
with clinical monitors
• Ensure the quality of project data by developing and applying comprehensive validation
procedures prior to the migration of data
• Implement production databases at the start of each project to enable data cleaning to occur at
an early stage; co-ordinate the design of record forms/screens for Local studies.
• Communicate effectively with International Project team, and Corporate Computing Support
• Provide training and support for Hospital Investigators and Study Staff; communicate effectively
with investigational sites to resolve data clean-up queries
• Maintain systems to track the data management process
• Develop and maintain project data management plans and co-ordinate the activities of informal
project data management teams comprising Clinical Research Officer(s), Data Entry, Data
Analyst and external Contract Research Organisation staff to ensure adherence to agreed
schedules
• Advise Clinical Data Co-ordination Specialist of resourcing requirements to meet project
workload requirements
• Assist the Clinical Data Co-ordination Specialist in providing technical training and undertake
assigned technical special projects
Qualifications:
• Recognised degree in appropriate life science(s) or mathematics/ computing with experience of
clinical research
• At minimum of 2 years experience in clinical research data management within the
pharmaceutical or contract research industry
• Good communication skills
• Looking for the more senior end of a Data reviewer
• Hands-on data review experience and study lead/project management experience.