Clinical Trial Liaison (CTL)

Business Unit: Clinical Development & Operations

Reports to: Field Manager, Amplity Health / Regional Lead CTL

Location(s): DACH

Territory: DACH (Germany, Austria and Switzerland)

Individual or Manager: Individual

Purpose of Role

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.

Key Accountabilities
• Provides country/regional operational insight into site feasibility and selection and... overall patient recruitment strategy
• Participates 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
• Participate in site visits with investigators site staff and CRO representatives in support of clinical trial execution and report back to study teams e.g. feasibility, start-up activities, enrolment 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
• 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/processes on an ongoing basis
• Act as field-based reference point of scientific and clinical expertise for study sites.

Education

Essential Skills, Knowledge and Experience
• Pharmacist, PhD, MSc in a relevant scientific field or associated qualification (preferred), BSc. min. requirement
• Fluent written and spoken English (mandatory) and local language of country to be covered

Experience
• Minimum 5 years relevant experience in pharmaceutical industry
• MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience e.g. CRA (Clinical Research Associate) preferred, KAM (Key Account Manager) with Clinical Trial background possible
• Clinical trials experience and understanding of clinical trial methodology and management
• Experience of working within relevant therapeutic area
• Experience in management of KOLs, Researchers and HCPs at all levels in both 1:1 and group settings
• Experience of working within the relevant National Pharmaceutical Codes of practice.

Skills
• Communication and strong, 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, whilst contributing positively to the Clinical Operations Function
• Ability to drive performance of self and others
• Highest ethical, transparent standards

Job Requirements
• Extensive experience in global clinical trial operations required
• Experience in Oncology trials a role requirement
• High travel required – International responsibility may be required, flexibility needed
• Extensive medical and scientific knowledge and clinical development understanding
• Excellent communicator of technical and scientific information
• Excellent interpersonal skills, ability in both in-person and virtual engagement of HCP’s
• 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. Must be able to prioritize and

manage a high volume of studies – Pharmaceutical company have a very large cross-therapeutic

portfolio of clinical trials being run globally
• Cross cultural awareness and fluent in at least one commonly spoken European language in addition to

English
• A working knowledge of ICH/GCP

Team Membership And Key Interfaces

List key team memberships and cross-functional interfaces essential for success in this role

Key Team Membership
• Clinical Study Team Meeting(s)
• Clinical Operations Review Meeting(s)
• Clinical Compliance and Quality Meeting(s)

Cross Functional Interfaces
• Clinical Project Management and Operations
• Medical Affairs
• Regulatory Affairs
• Medical Director(s)

About Amplity

Amplity Health is the true partner of global healthcare companies who builds transformational solutions by

challenging the boundaries of commercialization strategies to improve the lives of patients.

We Do This Through
• Commercialization – Amplity Health has the expertise, people and infrastructure to meet a wide range of commercialization challenges
• Clinical & Medical Outsourced Solutions – Building end to end external engagement solutions and capabilities across clinical and medical affairs globally
• Consulting – Building end to end external engagement solutions and capabilities across clinical and medical affairs globally
• Remote Engagement – Alternative channels across the medical and commercial continuum to engage with HCPs and patients
• Field Outsourced Solutions – Tailored field team programs to meet a wide range of objectives and client needs

Values

These are our company values that we expect all candidates and potential employees to embody as these

Values Strongly Underpin Our Culture

Excellence

Passion

Integrity

Innovation

Collaboration

Amplity Health is an equal opportunities employer. Amplity Health believes that drawing upon the talents of people from diverse backgrounds and experiences enriches our performance. We seek to create an inclusive, fair, and respectful environment that celebrates individual differences and the unique perspectives they bring. Diversity at Amplity Health includes ethnicity, gender, age, religion, disability, national origin, and sexual orientation. It also encompasses recognizing the uniqueness of everyone’s characteristics, styles, and experiences. At Amplity Health, we believe our people are the foundation of our success.

Please note: If you have not received a response to your application within 4 weeks, you have not been successful on this occasion. Please register on our portal for other opportunities
St Pölten Austria

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