Clinical Trial Lead / Senior Clinical Trial Lead
- Clinical Development Operations
- Employment Type
- Full Time/In House
This In House position is responsible for managing aspects of a clinical trial at the direction of the Project Manager. The incumbent will provide logistical and operational support to Clinical Operations management and Project Managers. Supports the development and preparation of standardized clinical study tools, tracks progress of trial activities.
The main responsibilities of this role may include, but are not limited to, the following:
- Develop, maintain and manage appropriate study documentation.
- Set-up and maintain tracking systems/tools and report study metrics to support the clinical study.
- Manage activities conducted by CRO and other vendors as needed.
- Identify and follow-up on trial related reports and deliverables
- Develop study related documents in collaboration with the Project Manager.
- Assist with vendor management in collaboration with the Project Manager.
- Ensure Study team member deliverables and timelines are tracked and report to PM on progress.
- Participation in initiatives and/or other activities as directed.
- Laisse with Regulatory, CMC, Legal, Finance to manage related activities
- Interface with CRO vendors to address issues and ensure timely quality deliverables.
- Develop Recruitment and financial projections and report on progress
- Provide timeline updates to Project Manager
- Willingness to travel up to 25% of time.
Training and Education
Bachelor's degree or equivalent experience required (scientific or healthcare discipline preferred).
- 3 to 8 years related experience in clinical research within the pharmaceutical, biotechnology or CRO industries.
- Prior work with project teams in a Phase 3, clinical support role highly desirable
- Working knowledge of regulatory and ICH GCP guidelines.
- Proven clinical operations skills demonstrated by the ability to understand and prioritize requirements and deliver on time
- Ability to manage multiple priorities, identify problems and areas for improvement in clinical trial activities.
- Demonstrated experience in computer programs including Microsoft Word, Excel, and basic templates.
- Conscientious and precise in delivery of work even when under pressure
- Collaborative and team oriented
Please fill out the form below to submit your application.