SrLabProjectSet-UpCoord

Job Overview Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s); ensure work is conducted in line with standard operating procedures, policies and good practice. Accountability and ownership for the quality of database configuration. Essential Functions • Assist with study validation activities • Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements • Configure project database, where applicable • Maintain accurate project documentation files • Keep Setup Managers, 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) • Participate in local and global improvement projects as defined by the relevant process improvement management team • Participate in internal audits, as required • Communicate with study Sponsor(s) as needed (e.g. exchanging factual information) • Assist in the development of database design requirements for protocols and protocol amendments • Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues • Manage the set-up process for a low complexity study, where applicable. Mentor and assist in training more junior staff • Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice. Qualifications • High School Diploma or equivalent Req And • Bachelor's Degree Life Sciences or related field Pref • Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry. • r equivalent combination of education, training and experience. • Posses strong organizational and coordination skills. • Proven track record of quality, accuracy and attention to detail.