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Details

Monitoring and Investigator Site Management Systems Associate Consultant


Reference:POR/843457 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Data Manager

A Monitoring and Investigator Site Management Systems Associate Consultant is required to join a leading global pharmaceutical business based in Cork. This is an opportunity to join a vibrant multi-cultural and multi-lingual team where you will play your part in making a difference for people the world over by supporting the business as it discovers, develops, and delivers medicines that help people live longer, healthier and more active lives.

The role

The Associate Consultant, Monitoring and Investigator Site Management Systems (MISMS), will serve as a leader for systems supporting clinical data system development. In this role, you will execute implementation plans to deliver on the system strategies, integrations, and improvements for clinical data management systems. The Associate Consultant is responsible for collaborating with internal and external business partners to enable development, implementation, and support of streamlined, clear and compliant systems to support clinical development and operations.

Responsibilities:

    • Maintain and grow expertise in clinical information systems & business strategies, processes and technology as it relates to clinical development.
    • Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with Veeva Vault Clinical Platform.
    • Support internal audits and external inspections.
    • Define, lead, and execute implementation plans to deliver on technology strategies and improvements.
    • Develop & monitor critical success factors for pilots/projects and report progress to ensure clear criteria exists to enable decision making.
    • Identify, monitor, and communicate global customer (internal and external) needs/ requirements as related to process and/or technology performance and improvements.
    • Lead organizational change, communication planning, and training initiatives related to the adoption and implementation of VC functions.
The Person:
    • Bachelor’s degree in science, IT or health related field
    • Minimum 4 yrs experience in medical, quality, clinical drug development, or clinical information flow
    • Advanced degree in relevant field preferred
    • Experience in clinical development data systems as well as current and evolving technologies to support clinical development
    • Good interpersonal and leadership skills
    • Excellent oral and written communication skills

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie