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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.

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Clinical Data Co-ordinator

  • 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.