PURPOSE
Provide pre-launch database support; assist with designing, loading, and validation of generic clinical research protocol and the corresponding database; ensure work is conducted in line with standard operating procedures, policies and good practice; and lead project close-outs processes as required.
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.
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Update and maintain internal databases with generic project information and input project specific information, as directed (e.g., actions/issue log, status sheets and timelines).
Maintain project documentation files that provide project status and escalation.
Work through protocol questions, issues, escalations and changes with relevant senior coordinators (e.g. study specific) and managers.
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 coworkers and managers.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
High school diploma and relevant database 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.
May require occasional travel.