Coordonnateur(trice) principal(e), Mise en place de projets de laboratoire/Senior Laboratory Project Set-Up Coordinator

IQVIA•Mississauga, ON

2d•CA$60,000 - CA$100,000•Remote

About The Position

The incumbent provides project-related operational support, including the design, loading, and validation of laboratory databases within Clinical Trials Management Systems. They ensure that work is conducted in accordance with standard operating procedures (SOPs), internal policies, and good professional practices. They are responsible for the quality and accuracy of database configuration.

Requirements

Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry or equivalent combination of education, training and experience.
Possess strong organizational and coordination skills.
Proven track record of quality, accuracy and attention to detail.
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 environment.
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.

Nice To Haves

Bachelor's Degree Life Sciences or related field Preferred.
Enhanced technical and operational knowledge, especially in the area of Clinical Trial Management Systems (preferred).
Knowledge of Laboratory processes and computer systems helpful.

Responsibilities

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.