Use knowledge of Protocol specific and routine tasks to ensure outputs are delivered in line with organizational standards and client expectations.
Conduct tasks that support all phases of the relevant project-specific protocol, including but not limited to giving input into the design of the monitoring plan to adequately monitor the project and completion of protocol -specific laboratory manuals and flow charts and leading project close-out processes and or one-region studies;
may lead small complex global study under support from the line manager.
Prepare and maintain project documentation files and update and maintain internal databases with project specific information.
Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies.
Liaise with other departments and support services (e.g. Logistics Department, courier services) in order to expedite the transportation of patients’ laboratory specimens.
Perform technical reviews and feedback comments and changes to project managers.
Participate in external and internal audits.
Maintain effective systems for project documentation.
Develop and present information effectively to internal & external audiences, where the information is specific to the role and protocol, such as lessons learned, audits and sharing best practices (e.
g. department training).
Contribute to the development Investigator Meeting presentations.
Liaise with study Sponsor as required.
Submit revision requests and / or budget re-pricing requests on behalf of the Project Manager; recognize budget impact of change to project scope and may communicate budget change impacts to client.
Be knowledgeable of monitoring plans performed by the PC RT staff. This includes the day-to-day running of designated projects, including patient specimen management receipt, pending lab analyses, and test result approvals and reports and other duties as detailed in the project-specific monitoring plan.
Mentor and assist in training more junior staff, including project coordinators.
Lead client calls and discussions for a one region study, as required; escalate points and or information accordingly.
May manage the entire project management process for a one region, low complexity study with the oversight of a Project Manager.
May host Project Launch meetings or other internal meetings on behalf of the Project Manager.
May provide back-up to the Project Manager in periods of the Project Manager’s absence from the office.
Contribute to process improvement initiatives
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Requires protocol specific knowledge
Good organizational and operational skills
Good accuracy and attention to detail skills
Strong written and verbal communication skills including good command of English language
Computer proficiency in word processing, presentation, and spreadsheet applications
Demonstrated ability to work in a fast-paced, high stress environment highly desirable
Ability to work with limited support through complex global trials
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Knowledge of Quintiles Laboratories processes and computer systems (includingQLIMS, QLIMS2000, QNET) helpful
Job ID : R1112963