Clinical Trial Manager - Neurology (Virtual)
Multiple Locations: Austin, TX, USA • United States
Notice
Requisition Number: 2442
Position Title: Clinical Trial Manager
External Description:
*A $10,000 sign-on bonus is offered for this position.
The Clinical Trial Manager (CTM) is responsible for leading the delivery of clinical study site management activities through the coordination of a team of Clinical Research Associates (CRAs) within a geographic region.
The CTM will ensure site qualification, initiation, interim monitoring, site management, and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs).
This role is responsible for the overall quality and timeliness of clinical deliverables for the assigned programs and region and will act as Trip Report Reviewer.
RESPONSIBILITIES:
- Collaborate with Project Management to set site management monitoring strategy and ensure compliance with project goals and Worldwide processes
- Point of contact for clinical monitoring and site activities within the project including:
- Primary Site Management (SM) Sponsor contact
- Investigator and Bid Defense Meeting
- Internal and External study team calls
- Project-specific Audits / Inspections
- Manage monitoring deliverables and identify Out of Scope Activities
- Provide CRAs training all clinical aspects of the study
- Lead the tracking of recruitment and revision of site-specific recruitment plans to ensure enrollment stays on target
- Provide and monitor regular analytics
- Oversee Trial Management File (TMF) compliance of SM documents
REQUIREMENTS:
- Bachelor’s degree required plus 3 years experience as a CRA
- In lieu of a bachelor’s degree, a two-year nursing degree plus 5 years as a CRA may be considered
- Minimum 6-month experience functioning as Clinical Trial Manager or Lead CRA Required
- CNS/Neurology experience required
- 25% travel required
- Valid current passport required
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City:
State: Pennsylvania
Employment Type: Regular
Community / Marketing Title: Clinical Trial Manager - Neurology (Virtual)
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.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.