Territory includes: Poland & possible other EU countries as needed
The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the local field-based representative for the sponsor company in one or more countries/regions supporting clinical development programs. The CTL interacts with investigator sites and other parties related to clinical trial execution.
The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both identifies and helps facilitate resolution of investigator site issues.
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 global clinical trial operations, site facing required
• Multiple therapeutic areas, general medicine and rare disease)
• 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
• A willingness to travel frequently within assigned geographical territory, including overnight travel.
• Valid driver’s license
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