Position

The Director Study Site Engagement & Monitoring Excellence (CONTRACT) will be responsible for leading the development and execution of Eikon’s global trial site engagement strategy, including oversight and accountability for all internal/external managed site monitoring activities to ensure predictable delivery of high-quality data and establish Eikon as a preferred sponsor for clinical sites.

The Director will ensure effective collaboration with clinical study teams, and Functional Service Provider (FSP) partners, to implement excellent site relationship management and site monitoring activities to accelerate operational excellent delivery of Eikon’s clinical programs.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

What You’ll Do

Strategic Leadership

• Define and implement site engagement strategies to improve relationships
• Support the build of new partnerships and networks
• Support high quality monitoring approaches and ensure alignment with regulatory standards
• Serve as liaison between clinical study teams and investigative sites

Operational Support

• Provide guidance, oversight and training to the study site engagement team, including CRA site monitors, whether insourced or outsourced suppliers, to maximize effectiveness and acceleration in Eikon’s operational execution of clinical research.
• Develop and maintain appropriate performance standards, processes and documentation for harmonized site engagement and monitoring support across Eikon’s clinical programs.
• Maintain regular information exchange within the study site engagement team, identify common elements of study support across regions/countries to codify and apply lessons learned, troubleshoot issues and distribute acquired site intelligence to Clinical Operations study teams and Clinical Development stakeholders as required.
• Oversee resource and talent management of site engagement team, including CRA monitors, whether insourced or via outsourced suppliers, across relevant regional/country clusters to maintain quality of monitoring that deliver and achieve Clinical Operations study team goals.
• Accountable for overall oversight and training of FSP, study site engagement and CRAs by country/region, including identifying and managing CRA performance issues. Responsible for ensuring associated corrective and preventative actions are put in place, and that ICH GCP compliance, regulatory, quality and timeline objectives are met for all trials executed globally.
• Responsible for site and monitoring quality using interpretive signals in conjunction with local country intelligence to proactively identify risks.  Lead risk assessment at the site/country level for designated studies, including identification of mitigation and control.  Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.) and demonstrate use of data to enhance quality and accelerate study delivery. Track site engagement metrics and satisfaction scores.
• Demonstrate a learning culture by ensuring site quality and trends, including preventative actions are shared across study & assets in the clinical programs to drive accelerated drug delivery.
• Be the point of escalation for issues that arise in site engagement, escalating as necessary and keeping the relevant Clinical Operations study team informed of escalation and resolution. Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Manage functional budget, including resource projections, capacity assessment and vendor (e.g., FSP) oversight and evaluation, to ensure adequate and appropriate resourcing for Eikon’s clinical trial portfolio.

Cross Functional Collaboration

• Align with global Clinical Development stakeholders to ensure strategy and approach for clinical programs and studies is appropriate to meet study goals while incorporating study engagement team, including CRA monitors.
• Contribute to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes and clinical system capabilities to consistently deliver operational excellence.
• Collaborate with Clinical Development leadership to partner on important projects and stay current with relevant industry trends and innovations to ensure best practices in study site engagement are applied across Eikon.
• Serve as a talent magnet and develop, coach, and retain top talent in the team. Set clear performance standards and holds self and organization accountable for achieving results. Embraces metrics and performance standards (KPIs).

Qualifications 

• Post Graduate degree with 10+ years of experience or a Bachelor’s degree with 12+ years of experience in a relevant field, such as Life Sciences, Nursing, or a related discipline.
• Significant management experience in oncology clinical trial setting with the ability to effectively collaborate with different Clinical R&D stakeholders in a matrix organization. Management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and global/regional regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication. Skills in more than one language are an advantage in this role.
• Strategic thinking and high emotional intelligence.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.
• Travel: up to 25% travel expected​

The expected hourly range for this role is $100.50 to $121.00 depending on skills, competency, and the market demand for your expertise.