Clinical Trial Liaison

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.

Core 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

Qualifications:

• 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 inclinical trial operations required.
• Extensive medical and scientific knowledge and clinical development understanding.
• MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience) preferred; KAM (Key Account Manager) with a clinical trial background possible.
• 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.

Skills:

• 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.

Team Membership and Key Interfaces:

Key Team Membership:

• Clinical Study Team Meetings
• Clinical Operations Review Meetings
• Clinical Compliance and Quality Meetings

Cross-Functional Interfaces:

• Clinical Project Management and Operations
• Medical Affairs
• Regulatory Affairs
• Medical Directors

Credentialing Requirements:

As a representative of a pharmaceutical company, you may be required to submit and maintain credentials, such as training, vaccinations, and other job-related documentation to gain access to hospitals or healthcare providers. It is the Company's expectation that you comply with the requirements outlined by the facilities on your call plans.

Additionally, certain geographic jurisdictions or hospital systems have requirements to apply for and obtain a representative license. At this time, representatives working in the District of Columbia, City of Chicago, State of Nevada, State of Oregon, or those associated with Jackson Memorial Health in Miami-Dade County Florida may be required to obtain specific licenses. This list may be subject to change, including the potential for additions or modifications. In the event of any significant changes, you will be notified accordingly.

EPIIC Values:

All positions at Amplity have a responsibility to demonstrate our EPIIC Values in order to uphold our high-service standards.

Excellence: We set high standards. We are solutions-focused and achieve outstanding results with a professional and positive attitude.

Passion: We love what we do. Our energy inspires, engages, and motivates others.

Innovation: Our ideas set us apart. We are curious and bold and challenge traditional ways of working.

Integrity: We are open, honest, and transparent. We do the right thing with courage and understanding.

Collaboration: We are better together. We actively seek the participation of others to achieve greater outcomes.

About Us

Amplity powers biopharma innovation through expert-led teams that deliver. Whether you knew us in the 80's as Physician Detailing Inc., or in the 00's as part of Publicis Health , the companies that came together in 2019 to form Amplity have delivered contract medical, commercial + communications excellence for 40+ years.

Our people-driven, tech-enabled DNA fuels everything we do.Our professionals understand the pharmaceutical industry from the inside out. With a deep grasp on product lifecycles, marketing hurdles, operational nuances + the complex needs of providers and patients, we help our clients launch products + operate smoothly with precision - across all business shapes, sizes + specialties.

We are on a mission to improve patient outcomes through executional excellence - enabling our partners in pharma to thrive in turn. At Amplity, we are allies in excellence. And we do it quicker, better, nicer than anyone else.

Our Diversity Policy

We encourage and support equal employment opportunities for all associates and applicants for employment without regard to sex, race, color, religion, national origin, age, disability, marital status, sexual orientation or veteran status. Employment decisions are evaluated on the basis of an individual's skills, knowledge, abilities, job performance and other qualifications. In addition, Amplity Health maintains policies and procedures designed to comply with applicable federal, state and local laws governing non-discrimination in employment in every location in which Amplity Health has facilities.