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