Senior Clinical Research Associate
Parexel
Google Cloud Platform
Clinical Trial Project Manager
WEP Clinical
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Serve as the project team lead and primary client contact for clinical trials, overseeing operations, deliverables, and issue resolution.
- Manage the setup, execution, and close-out of trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and regulatory requirements.
- Provide accountability for day-to-day trial operations as defined by the contract and applicable regulations.
- Develop and maintain study manuals, operational project plans, timelines, and performance metrics.
- Assess countries and sites for feasibility to conduct clinical trials.
- Lead and coordinate cross-functional project teams (e.g., monitoring, site management, data management, PV, medical writing, regulatory, training, IP supply).
- Ensure internal and external teams are properly trained on operational aspects and therapeutic areas.
- Identify, assess, mitigate, and manage risks throughout the project lifecycle.
- Manage submissions to IRB/ECs, review local informed consent forms, and ensure accurate trial documentation (eTMF, CTMS, shared systems).
- Coordinate and lead internal and external meetings and teleconferences, ensuring effective communication across teams.
- Oversee vendor management, quality standards, project budgets, scope of work, and review/approval of vendor and site invoices/payments.
- Liaise with Quality Assurance to support audits, investigations, and CAPAs.
Requirements
- Bachelor's Degree (health or science field preferred)
- 3-6+ years’ experience in project management, clinical trials, and/or clinical research (or equivalent combination of education, experience, and expertise)
- Working knowledge of current ICH GCP guidelines
- Strong organizational skills and attention to detail
- Computer literacy and proficiency in Microsoft Office
- Leadership and management skills
- Effective verbal and written communication skills
- Ability to manage multiple priorities
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Willingness and ability to travel as needed for business meetings, trainings, and/or industry events
- Adaptable
- Detail-oriented
- Collaborative
- Solutions-focused
