InForm Support Analyst

Stockley Park, Middlesex (GBR)
£40 - £48 Per Hour
12 Months
Start date: ASAP
Ref: GSK0JP00081132

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Skills

implementation
gcp
vendor management
user acceptance testing
pharmaceutical
fda
documentation
problem management
system validation

Job description Posted 10 March 2020

InForm Support Analyst

Uxbridge

Up to £48 per hour (Umbrella Only)

12 Months

Are you an experienced InForm support professional? Are you energised by solving problems that are a mixture of people, process and technology within a faced paced environment?

If yes, this is a fantastic opportunity that will utilise your problem management skills and build your expertise in InForm support, vendor management and computer system validation in a pharmaceutical environment.

The Role

Within GSK R&D, we have a dedicated organisation that ensures our clinical systems are validated, compliant and remain fit-for-purpose during their entire lifecycle.

Accountabilities of the InForm Support Analyst include:

Provide exceptional customer focussed support of InForm, Central Designer & UMT tools - involves working directly with users and vendor helpdesk to resolve issues
Develop and maintain computer system validation documentation including independently managing and leading User Acceptance Testing assignments
Partner with InForm Business System Owner to ensure the system remains compliant, validated and inspection ready (GCP, FDA CFR Part 11 etc)

Successful candidates are typically, inquisitive, comfortable with technical concepts, possess high personal integrity, courageous, accountable and able to work with colleagues across a host of geographies and functions.

Basic Qualifications:

• Solid Oracle InForm (EDC) and Central Designer support experience

• Computer system validation experience within a pharmaceutical GCP setting

Preferred Skills

Deep understanding of Oracle’s InForm EDC product – able to articulate how its configuration, implementation and integration impacts business processes
Experience of leading the validation of computer systems within a regulated pharmaceutical environment
Clinical Data Management experience
Able to demonstrate good knowledge of processes, procedures and regulations (GCP, ICH, FDA CFR Part 11) related to clinical data management and sponsor obligations relating to computer systems.

Additional information about the process

All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!

Join GSK’s vision to do more, feel better and live longer:

https://www.youtube.com/user/gskvision/

Who will I be working with?

http://www.gsk.com/en-gb/careers/meet-our-people/