Lead Clinical Site Ambassador; Remote

The Lead Clinical Site Ambassador is accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs. This role ensures that clinical trials are executed with high quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies. Operating within a matrix environment, this role partners with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks.

The role is pivotal in maintaining sponsor oversight, validating the effectiveness of study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks.
This role plays a pivotal role in building and managing meaningful productive relationships with KOLs and key investigator sites and is eligible for remote consideration.

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 needed

• 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

Qualifications and Experience

Required:

At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. (Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).

• A minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry.

• Previous experience in leading and managing a team of professional staff.

• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.

• Experience in site management and monitoring and overseeing large and/or complex global clinical trials.

• Robust budget forecasting and management experience.

• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process

Competencies

• Demonstrated ability to lead teams and work in a fast-paced team environment.

• Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment

• Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities.

• Ability to evaluate, judge and make decisions regarding staff. Ability…