Clinical Trial Liaison - Lazio, Italia - Tnf Italy

Descrizione

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Job Description:
Come join the true partner of global healthcare companies, Amplity Health.

We continually challenge the boundaries of medical and commercial strategies to accelerate the approval and launch of new drugs to improve the lives of patients.

Job DescriptionClinical Trial Liaison (CTL)

Business Unit:

Clinical Development & OperationsReports to:Field Manager, Amplity Health / Regional Lead CTLLocation:ItalyTerritory:ItalyIndividual or Manager:IndividualPurpose of RoleThe 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 trialexecution.

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, startup 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 fieldbased reference point of scientific and clinical expertise for study sites.

Essential Skills, Knowledge and ExperienceEducation:

• 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 coveredExperience:
• 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 fieldbased setting, whilst contributing positively to the Clinical Operations Function
• Ability to drive performance of self and others
• Highest ethical, transparent standardsJob 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/

GCPTEAM MEMBERSHIP AND KEY INTERFACES:
List key team memberships and cross-functional interfaces essential for success in this roleKey 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 AmplityAmplity 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 needsValuesThese are our company values that we expect all candidates and potential employees to embody as these values strongly underpin our culture:ExcellencePassionIntegrityInnovationCollaborationAmplity Health is an equal opportunities employer if you require any reasonable adjustments to complete your application or attend an interview, please contact Laura Franco on
  USWe have a 40year track record of delivering solutions for Pharma and Biotech companies large and small.

Our wide-ranging capabilities include clinical and medical outsourced teams; clinical and medical capability development; companion diagnostic and precision medicine solutions; medical communications; expert engagement; remote and field solutions for patients, payers, and physicians; and strategic and access consulting.

Therapeutically, we cross many areas but have been a leader in oncology and rare diseases.

Our one-of-a-kind Insights database offers clients a detailed view into patient-provider interactions and provider treatment rationale not found through any other provider.

Every offering, every touchpoint, every solution is designed to ensure our pharmaceutical client's patients gain access to and benefit from the best medicines for the right reasons.

OUR CULTUREOur company values align to our partnership vision and define our culture.

These EPIIC values are reinforced in our people, our processes, and the solutions we provide for our clients:
Excellence, Passion, Innovation, Integrity, and Collaboration.

We believe that delivering on true partnership for our clients begins and ends with our own team, which is why we relentlessly recruit and maintain teams devoted to living our EPIIC values.

The result? An inclusive, collaborative, and respectful culture we are proud of.

We hold one another accountable to maintaining a safe workspace where we challenge one another to bring our best selves to work each day.

You will never feel unsure about how our EPIIC values look when lived out.

We make conscious efforts to model and reward behaviors that remind our colleagues, clients, vendors, and partners what we stand for.

We foster a sense of belonging by ensuring contributions are heard and respected. We want every member of the team to feel like they have a voice and they can use it.

Constantly challenged and always supported, each member of our team is empowered to create innovative, meaningful outcomes for our clients.

Opportunities with Amplity offer competitive compensation and dependent on the opportunity could include a comprehensive benefits package and 401K benefits.

To learn more about us, visit our website at or our social media pages, and DIVERSE PERSPECTIVESWe passionately champion a culture of belonging, with transparent company practices that drive diversity, equity, and inclusion.

Our commitment to inclusion is core to who we are. We welcome people with diverse backgrounds and perspective who ignite curiosity and challenge the status quo.

As a provider of services across 6 continents, our team is as diverse as the clients we serve and the countries we work in.

We seek to create an inclusive, fair, and respectful environment that celebrates the individual differences and unique perspectives each person brings; where everyone feels a sense of belonging and can be their true, authentic, and best self.

As an equal opportunity employer, we welcome everyone to our team. We promise to maintain a safe working environment where team members can thrive. The IDEA - Amplity's Inclusion, Diversity, and Equity Alliance - makes sure of it.

The IDEA helps our organization embrace diverse business practices, creates a sense of community through colleague resource groups, reminds our leaders to sponsor and embrace diversity, equity, and inclusion, and encourages cultural competence and awareness through company-wide resources for learning.

Our commitment to diversity spans our people, our processes, and our suppliers.

OUR DIVERSITY POLICYWe 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.