Responsibilities
- Clinical Oversight & Compliance
- Responsible for operational oversight of the site, site health and monitoring activities
- Support QA audit and inspection planning, and implementation of CAPAs as needes
- Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs.
- Study Delivery Support
- Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
- Support sites in understanding study expectations, timelines, and required deliverables
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
- Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs
- Site Relationship & Engagement
- Build and maintain strong, trusted relationships with investigators and site staff – Face of CSL
- Serve as the sponsor primary point of contacted for assigned studies
- Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration
- This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%
- Continuous Improvement & Site Experience
- Collect feedback from sites and advocate for process simplification and burden reduction internally
- Identify opportunities to improve study materials, and operational processes
- Represent the “voice of the site” in cross-functional discussions and initiatives
- Feasibility & Site Selection
- Provide local site intelligence to feasibility teams
- Support site development
Requirements
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
- 10 years + clinical research experience within the pharmaceutical industry
- Experience in leading / managing a team as well as in site management, monitoring and overseeing large and/or complex global clinical trials
- Must have a strong understanding and experience in drug development process and specifically each step within the clinical trial process
- Must have strong budget forecasting and management experience
- Extensive experience and knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Experience / ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
- Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
Additional Information
- This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%
