Clinical Trial Liaison (CTL), Thromboembolic Disorders(West)

Duties and Responsibilities

• Provide country/regional operational insight into site feasibility and selection and overall patient recruitment strategy
• Participate in Clinical Study Team Meetings and Quality Review Meetings where necessary providing input to study teams on operational issues based on site visits and contacts
• Attend and present at 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
• 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
• 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
• Manage travel and local expenses in accordance with sponsor and TMAC policies

Qualifications and Experience

• Minimum Bachelor’s degree, master’s preferred or terminal degree (MD, PhD or PharmD)
• 8+ years relevant industry and/or CRO experience required
• Extensive experience in site facing clinical trial operations required
• Hematology (thromboembolic disease)/Cardiology clinical trial experience
• 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
• 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
• A working knowledge of ICH/GCP
• Computer skills including Excel, Word, and PowerPoint
• A willingness to travel frequently within assigned geographical territory, including overnight travel
• Valid driver’s license