Provide pre-launch database support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System [examples QLIMs, NewLIMs, TOPCAT, Encompass]; ensure work is conducted in line with standard operating procedures, policies and good practice.

RESPONSIBILITIES

• Configure project databases.
• Input data into the databases adhering to design specifications.
• Support online protocols and amendments.
• Perform a database configuration review and assist with validation of database specifications.
• Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements.
• Maintain project documentation files.
• Keep Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.
• Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings).
• Develop solutions for routine project related issues and problems, within a limited scope.
• Participate in local and global improvement projects as defined by the relevant process improvement management team.
• Participate in internal audits, as required.
• May have occasional, limited contact with study Sponsor(s) (e.g. exchanging factual information).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good organizational and operational skills
• Good accuracy and attention to detail skills
• Good written and verbal communication skills including good command of English language
• Computer proficiency in word processing and spreadsheet applications
• Demonstrated ability to work in a fast-paced, high stress environment highly desirable
• Ability to establish and maintain effective working relationships with co-workers and managers.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• High school diploma or equivalent and 4 years’ relevant experience; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.