Remote Position
[Remote] Director, Clinical Trial Liaison - West
๐ Remote ยท United States
๐ผ Full-time
Note: The job is a remote job and is open to candidates in USA. Kardigan is a heart health company developing targeted treatments to address cardiovascular disease. The Director, Clinical Trial Liaison will support clinical trial execution across the West region by developing investigator and site relationships, facilitating recruitment and retention, providing regional operational insights, and resolving site issues. The role will collaborate with clinical operations, clinical development, medical affairs, CROs, and investigator sites, with frequent travel of up to 70%.
Responsibilities
- Provide country/regional operational insight into site feasibility and selection and overall patient recruitment strategy
- Identify and cultivate high-quality cardiovascular investigators
- Communicate scientific and clinical information clearly and accurately, ensuring sites understand study objectives, rationale, investigational product profile, and any updates or amendments
- Collaborate with Clinical Operations and Clinical Development
- Participate in clinical study team meetings and quality meetings where necessary providing input to study teams on operational issues based on site visits and contacts
- Attend and present at SIVs, investigator meetings, monitor workshops/training
- Participate in site visits with investigator site staff and/or CRO representatives, or independently, in support of clinical trial execution and report back to study teams e.g. feasibility, startup activities, enrolment or escalated study/site issues
- Support enrollment and retention efforts through tailored discussion, data-driven insights, and strong relationship-building
- Responsible for review, documentation and follow up of investigator site issues including tracking metrics
- Provides sponsor regional operational support and acts as point of escalation for investigator sites as appropriate
- Identify and escalate site needs, barriers, or operational challenges to the Clinical Operations and Medical teams
- Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative
- Complete all administrative responsibilities consistent with SOPs and departmental guidelines including but not limited to required training, field activity documentation, expense reporting, and other assigned tasks
- Understand the scientific basis of assigned clinical trials
- Support creation of educational materials to effectively communicate the science behind the clinical trial
- Be able to communicate the scientific basis of the trials to other team members, investigators and site staff
- Identify effective prescreening strategies for each trial and recommend improvements
- Provide detailed reports of interactions with investigators and site staff
- Partner with Medical Affairs, Clinical Operations, and other cross-functional stakeholders to ensure consistent messaging and aligned site support
- Ensure all interactions comply with regulatory, ethical, and company standards
Skills
- Minimum Bachelor's degree
- 10+ years relevant industry and/or CRO experience required
- Extensive experience in site facing clinical trial operations required
- Extensive medical and scientific knowledge and clinical development understanding
- Excellent communicator of technical and scientific information
- Excellent interpersonal skills and demonstrated collaborative as well as independent working style
- Ability to build relations with the external medical community
- Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs)
- Strong organizational skills with effective use of time and prioritization
- Cross cultural awareness
- Fluency in English and in local language in country of residence required
- A working knowledge of ICH/GCP
- Computer skills including Excel, Word, and PowerPoint
- Valid driver's license
- Master's preferred or terminal degree (MD, PhD or PharmD)
- Cardiovascular clinical trial experience and expertise in cardiovascular disease (e.g., heart failure, cardiomyopathies, hypertension, cardiometabolic disease, etc.) preferred
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