Mycobacteriology Development Lead

Job Overview

Responsible for Project Management operational delivery. Serve as key contact for internal/external business relationships. Manage the design/launch of non-standard, complex clinical research studies as assigned. Review processes, to develop, integrate, administer and maintain current Project Services systems; provide expertise to Project Services on ways to improve project execution and/or database design and implementation. May assume oversight of specific programmes. Serve as mentor for the Project Services team and develop/maintain best practices within the organization. Ensure work is conducted in line with standard operating procedures, policies and good practices.

Essential Functions

• Study Setup and Planning:

• Facilitate seamless study set-up including Protocol and Budget review, leading meetings. Develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Will prepare and present protocol-specific materials at Kick Off and Investigator meetings

• May participate in the proposal and business development process including bid defence meetings. Will lead in the development of Customer standards. Will lead Customer meetings / presentations in partnership with Senior Project Services / Operational / Business Development staff

• With experience may perform technical review at program / project initiation. Will manage more complex studies (e.g. Companion Diagnostic, multiple region studies)

• Study Activity Monitoring and Closeout:

• Will monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Custo...

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