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Clinical Trial Business Support Analyst
Requisition ID: 75795
Position: Full-Time Regular
Research & Development
Stockley Park, London
Required degrees: Post Grad Diploma
Associate Degree; HND/HNC Degree or Bachelors Degree; with proven applicable experience
Experience in pharmaceutical industry including clinical trial EDC (Electronic Data Capture) technical experience. Examples of experience may include:
- Setting up clinical trial eCRFs (Inform preferable)
- Programming data validation checks in SAS or SQL
- Supporting data management users in the use of clinical trial systems
- Developing SAS/SQL reports
- Solid technical background and computer proficiency in a variety of clinical trial systems and databases
- Solid knowledge of data management clinical trial processes and procedures, including regulations as required (e.g. GCP, CFR Part 11)
- Exhibits enhanced customer service orientation and excellent interpersonal skills with ability to communicate professionally to diverse cross functional non-technical and technical audiences
- Track record of solving technical problems/issues i.e. technologically inquisitive
- Experience of Client/Software Vendor Management including:
- Proven ability to build up effective working relationships with vendors / suppliers / business partners
- Influencing the ‘system roadmap’ of a software vendors product
- Managing the resolution of critical business system issues with external vendors
- Negotiating win:win solutions with business/IT and vendor partners
Experience of managing system upgrades from a business perspective including:
- Business requirements gathering
- Executing/Managing UAT activities
- Communicating changes to business users
- Creating training documentation
- Maintaining system validation documentation
- Experience of developing eCRFs and/or supporting Oracle Inform v4.x or another EDC product
- Software development experience in a regulated pharmaceutical environment
- 1st and/or 2nd level clinical trial system support experience
GlaxoSmithKline is one of the world's leading research based healthcare companies, with operations in over 100 countries and 96,500 employees worldwide. We discover, develop, manufacture and distribute a huge range of healthcare products, from lifesaving prescription medicines and vaccines to popular consumer healthcare products like Lucozade, Ribena, Horlicks, Sensodyne, Aquafresh and Panadol. Delivering more than 1,400 brands to over 160 markets across the globe, with an annual turnover in excess of £28 billion. We're dedicated to helping millions of people around the world to do more, feel better and live longer.
The purpose of the Clinical Trial Business Support Analyst is to provide high quality business support for our end-to-end clinical trial systems. Many of our systems are used by a global community spanning thousands of users. We’re at an exciting point in our evolution as we continue to push the boundaries of our clinical trial technical landscape.
Primary responsibilities include:
- Acting as the single point of contact within the business for Inform v4.x
- Provide 2nd line help desk support for Inform queries ensuring timely and acceptable resolution through liaising with external vendors and internal business and IT partners
- Communicate effectively with vendors and customer groups to ensure desired service outcomes, notify customers of any planned downtimes, changes or upgrades to the system &/or training and documentation
- Develop strategic partnerships with external vendors, internal business and IT groups
- Partner with internal/external groups to periodically upgrade the version of Inform
- Continuously improve clinical trial systems and workflows to deliver impactful benefits
- Ensure the Inform v4.x system conforms and remains compliant with regulatory validation requirements i.e. ICH GCP, FDA CFR Part 11.
This position is an opportunity to join an experienced clinical trial systems support organisation that values the contribution of its people and empowers them to make an impact in our pursuit of delivering high quality clinical studies.
Please click the 'Apply Now' button to submit your applicatoin via the online application system.
Closing date for application : 10th Sept 2012
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Applications without a cover letter will not be considered. Additionally, applicants who previously applied for the ‘Inform Support Analyst’ role (ref: 75795) will not be considered.
Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.