The Clinical Trial Liaison (CTL) supports clinical study execution as the regional field-based representative for the Company supporting clinical development programs. The CTL interacts with investigator sites and other cross functional study team members related to clinical trial execution.
The CTL provides 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.
The CTL will provide operational insight into site feasibility and selection and overall patient recruitment strategy
The CTL will 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
Designs POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per clinical strategy
Analyzes the benefits and risk aspects of an assigned therapeutic candidate
Responsible for the relevance and accuracy of medical science underpinning of clinical study based on thorough scientific review and consultation with internal and external experts
Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments
Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions
Attend and present at investigator meetings, monitor workshops
Participate in site visits with investigators site staff and CRO representatives in support of clinical trial execution and report back to study teams eg. feasibility, start up activities, enrollment or escalated 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
Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative
Contributes to process improvement initiatives when required
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
Terminal degree(MD, PhD or PharmD) preferred or MSN, MSc
Clinical trial management experience
4 to 8 years of clinical research pharmaceutical industry experience and/or significant relevant experience in academic clinical trials
Has authored industry documents and/or has published in medical/scientific peer-reviewed journals.
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
Computer skills including Excel, Word, and PowerPoint
A willingness to travel frequently within assigned geographical territory, including overnight travel.
Valid driver's license
Posted On: Tuesday, September 10, 2019
The Medical Affairs Company