- Title: Clinical Trial Leader
- Code: RCI-FSP-1776
- Location: Irvine California (CA) 92618
- Posted Date: 04/22/2019
- Duration: open Months
- Status: Open
Talk to our Recruiter
- Name:Prince Dash
- Email: email@example.com
- Phone: 908-704-8843 ✖ 234
Clinical Trial Leader
- Clinical study execution in support of the Client’s team and their overall Clinical Center of Excellence with a focus primarily on clinical cardiovascular studies.
- Fostering strong, productive relationships with colleagues within the organization
- Serving as a member or leader of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility
- Overall execution of small-medium-large regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure
- Providing support to department wide training
- Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects
- Leading several small/medium/large clinical studies (regulated and non-regulated) that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
- Assisting with or leading the management of large regulated studies alongside and in support of colleague CPMs or Senior CPMs and may support CPMs and/or Senior CPMs within a large or complex clinical study.
- Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
- Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
- Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Evaluating support requests for publications and to provide consolidated comments and support to the requests.
- Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
- Tracking assigned projects budgets to ensure adherence to business plans.
- Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
- Independently solves problems arising during clinical study execution and will seek guidance for more complex problems as needed
- Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
- May serve as the primary contact for clinical trial sites
- A minimum of a Bachelor’s Degree required: Life Science, Physical Science, Nursing, or Biological Science degree is preferred
- 5+ years of experience required as CRO- or Sponsor-level CRA or Clinical Project Manager
- 1+ years of Clinical Project Management experience
- Cardiovascular clinical trial experience strongly preferred
- Personnel management experience strongly preferred
- Medical device experience is preferred
- The ability to influence others along with strong written and oral communication skills is required
- Knowledge of Good Clinical Practices is required
- Understanding and application of regulations and standards applied in clinical areas is required
- Advanced project management skills with the ability to handle multiple projects required
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
- Strong written and oral communication skills