Clinical Trial Liaison

Amplity Health•Philadelphia, PA

1d•Remote

About The Position

Join Amplity, the full-service go-to partner of biopharma companies that delivers flexible + specialized medical + commercial services. No matter where a drug is in its lifecycle, we scale with ease to maximize resources + improve impact for all our clients. Through strategic partnerships + deep therapeutic expertise, Amplity transforms how breakthrough treatments reach the people who need them. The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the local US field-based representative for Amplity. The CTL interacts with investigator sites and other parties related to clinical trial execution. The CTL provides 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.

Requirements

Minimum of a bachelor’s degree from an accredited university or college required with a terminal degree, Pharm D, Ph. D preferred. MSN, PA, NP may be considered with pharmaceutical experience
Pharmaceutical industry experience required, 5 years of relevant experience in the pharmaceutical industry preferred.
Extensive experience in clinical trial operations required.
Extensive medical and scientific knowledge and clinical development understanding.
Experience working within therapeutic area.
Experience managing KOLs, researchers, and HCPs at all levels in both 1:1 and group settings.
Extensive medical and scientific knowledge and clinical development understanding required
Technologically proficient with Microsoft Office Suite, digital meeting platforms and other software programs as needed.
Valid driver’s license with safe driving required
Successfully pass all required Amplity and client training
Willingness to travel in the US weekly 60%+ or greater including occasional evening or weekend engagements for professional events or programs.
Strong communication and collaborative interpersonal skills.
Demonstrable thirst for knowledge (technical, clinical, medical, scientific) with an ability to assimilate information quickly, present clinical data clearly and concisely, and discuss the statistical and clinical relevance in line with clinical development strategy.
Ability to work autonomously in a field-based setting
Ability to drive performance of self and others.
Extensive medical and scientific knowledge and clinical development understanding.
Excellent communicator of technical and scientific information.
Excellent interpersonal skills, with the ability to engage HCPs effectively
Proactive and self-motivated, with the ability to align activities with clinical development plans (CDPs).
Strong organizational skills with effective use of time and prioritization.
Must be able to prioritize and manage a high volume of studies.

Nice To Haves

MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience) preferred; KAM (Key Account Manager) with a clinical trial background possible.

Responsibilities

Provide 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 and monitor workshops.
Participate in site visits with investigator site staff and CRO representatives in support of clinical trial execution and report back to study teams (e.g., feasibility, start-up activities, enrollment, or escalated site issues).
Review, document, and follow up on investigator site issues, including tracking metrics.
Provide sponsor regional operational support and act as a point of escalation for investigator sites.
Participate in regulatory GCP inspections and/or audits at investigator sites as the sponsor representative.
Contribute to process improvement initiatives when required.
Perform oversight monitoring on a triggered basis, as required, and produce relevant reporting and feedback.
Ensure compliance with SOPs (Standard Operating Procedures), GCP (Good Clinical Practice), and other relevant guidelines and processes on an ongoing basis.
Act as a field-based reference point of scientific and clinical expertise for study sites.
Other responsibilities as needed