Senior Clinical Trial Manager

Job Title: Senior Clinical Trial Manager

Job Location: Virtual Australia

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:
Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
*SUMMARY: *Responsible for oversight and leading the delivery of clinical study site management activities through the co-ordination of a team of clinical staff on particularly complex studies (such as those that have a significant global reach). Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan. Uses data metrics and project planning to monitor and secure quality of data submitted from study sites and timely completion, including appropriate reporting and follow-up for all safety events by site personnel *RESPONSIBILITIES:*_Tasks may include but are not limited to:_ Provide leadership and direction to clinical site management team members from study start through closureOversee regional CTMs and coordinates efforts across the CTM teamRepresent Site Management issues at Sponsor, Investigator and Bid defense meetings and act as main point of contact for activities through the studyContributes to the overall project plan, by formulating a global monitoring strategy for site initiation, enrollment, site management and closeout phases across a given region and assigns sites on behalf of the sponsorProvide regular input to various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed Collaborates closely with other functions including Business Development, Regulatory, Study Start up and Project Management to anticipate requirements and achieve study goals When needed, assumes dual PM/CTM roleDevelop, maintain and ensure compliance with Clinical Monitoring Plans, including budgets, study tools and Site visit reports; perform regular review of protocol deviations, Out of Scope items and oversight of action items. Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as neededParticipate in the development of and implementation of recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on targetDrive efforts to improve the quality of the site data and deliverables and address any identified needs with action plans. Review data metrics to ensure data integrity and qualityReview of data trends and trip report issues identified for re-training of sites or CRA team. Escalate issues and trends per study expectations.Oversee TMF compliance of S