Director, Clinical Trial Liaison

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish connections with clinical trial investigators and research site personnel to enhance participant recruitment for Kardigan clinical trials.

• Act as the local field-based representative supporting Global Development clinical study execution.

• Engage with investigator sites and other stakeholders involved in the execution of clinical trials.

• Travel up to 70% as necessary to assist site teams, troubleshoot issues, and nurture collaborative relationships.

• Offer regional and country-specific insights to assess study feasibility, identify and select sites, and improve patient recruitment and retention.

• Identify and assist in resolving issues at investigator sites alongside the study team.

• Ensure that investigators and site staff have a clear understanding of investigational agents, eligibility criteria, and study protocols.

• Evaluate site strategies for identifying eligible participants and recognize competing trials or potential approvals affecting recruitment efforts.

• Serve as a liaison with key investigators, relaying site queries or concerns to the sponsor.

• Provide regional operational insights into site feasibility, selection, and patient recruitment strategies.

• Identify and nurture high-quality cardiovascular investigators.

• Communicate scientific and clinical information, encompassing study objectives, rationale, investigational product profiles, and updates.

• Collaborate with Clinical Operations, Clinical Development, Medical Affairs, and other cross-functional stakeholders.

• Participate in study team and quality meetings, site initiation visits, investigator meetings, monitoring workshops, and training sessions.

• Conduct or attend site visits, reporting on feasibility, startup, enrollment, and any escalated site issues.

• Enhance enrollment and retention through tailored discussions, data-driven insights, and relationship-building efforts.

• Review, document, follow up on, and track issues and metrics related to investigator sites.

• Act as the sponsor's regional operational support and escalation contact for investigator sites.

• Participate in Regulatory GCP inspections and/or audits as the sponsor’s representative.

• Complete SOP-compliant training, field activity documentation, expense reporting, and assigned administrative responsibilities.

• Assist in the creation of educational materials and communicate trial science to team members, investigators, and site personnel.

• Identify prescreening strategies and suggest enhancements.

• Provide comprehensive reports on interactions with investigators and site staff.

• Ensure that all interactions adhere to regulatory, ethical, and company standards.

⛳️ Requirements

• A minimum of a Bachelor's degree; a Master's degree or terminal degree (MD, PhD, or PharmD) is preferred.

• Over 10 years of relevant experience in the industry and/or CRO is required.

• Significant experience in site-facing clinical trial operations is essential.

• Cardiovascular clinical trial experience and expertise in cardiovascular diseases is preferred.

• Extensive medical and scientific knowledge along with a solid understanding of clinical development.

• Exceptional communication skills for conveying technical and scientific information.

• Strong interpersonal skills with a proven ability to work collaboratively as well as independently.

• Ability to establish relationships within the external medical community.

• Proactive and self-motivated, with an aptitude for aligning activities with clinical development plans (CDPs).

• Strong organizational skills with effective time management and prioritization abilities.

• Cultural sensitivity and awareness.

• Fluency in English and the local language of the country of residence is required.

• Working knowledge of ICH/GCP guidelines.

• Proficient in computer applications including Excel, Word, and PowerPoint.

• Willingness to travel frequently within the assigned geographical area, including overnight travel.

• A valid driver’s license is necessary.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and continuing education.

• Flexible working arrangements and a supportive work environment.