Clinical Trials Manager - General Medicine- Rare, Infectious Diseases, Respiratory - Australia, New Zealand

Requisition Number: 3980

Position Title: Clinical Trial Manager

External Description:

Position can be filled in Australia, Singapore, New Zealand

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.

What Clinical Operations Site Management does at Worldwide

Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve.

These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else.

At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. 

What you will do

• Responsible for ensuring site qualification, initiation, interim monitoring, site management, and study close-out activities for studies in accordance with the study protocol and study plan
• Ensure overall quality and timeliness of critical deliverables for assigned programs and/or region.
• Provide leadership and direction to clinical site management team members from study start through closure; training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and Sponsor as needed
• Point of escalation for clinical site management and investigator sites
• Draft (and finalize) the Clinical Monitoring Plan (CMP) and customization of Worldwide Clinical Trial monitoring visit report/letter templates, site/monitoring tools
• Assist in the design and development of additional study-related documents including (but not limited to) Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plan, etc.
• Track and reports to PM on compliance, trends and study metrics; responsible for the quality of the site data and addressing any identified needs with action plans with measurable metrics to ensure data cleaning is completed as specified
• Support the PM in ensuring the CRA team is staffed to meet the monitoring demands of the project or program in compliance with the approved budget and CMP; support PM in the development of, and implementation of, recruitment strategy in countries and sites assigned. Leads the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target.
• Follow up with CRAs regarding visits schedules, outstanding trip reports and follow up letters; review/finalize trip reports according to SOPs, expectations and as outlined in the annotated report
• May perform site qualification, initiation, interim monitoring, and/or closeout site visits as needed
• Represent clinical site management on sponsor and other relevant study team calls and may represent the Company as the primary contact on projects
• Conduct occasional co-visits for a specific study to ensure the quality of the site, of the CRA work and of the study procedures
• Ensure adherence and compliance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).

What you will bring to the role

• Excellent oral and written communication, organizational, problem-solving and interpersonal skills
• Ability to lead and motivate a team across locations and cultures
• Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
• Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines and local regulatory requirements
• Proficiency in Microsoft Office, CTMS, IVRS, and EDC Systems.

Your experience

• Bachelor’s Degree or a Nursing Degree required and a minimum of 8 years as a Clinical Research Associate
• Must have previous experience as a Lead CRA, Clinical Operations Lead or Clinical Trial Manager
• General medicine – Rare & Infectious Diseases, Respiratory experience required
• Willingness to travel required up to 30%
• Valid current passport required.

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. 

#LI-MM2
#LI-Remote

#rarediseases

#leadCRA

#studymanagement

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Employment Type: Regular

Community / Marketing Title: Clinical Trials Manager - General Medicine- Rare, Infectious Diseases, Respiratory - Australia, New Zealand

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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