Clinical Research Manager

1 settimana fa

Roma, Lazio, Italia Msd A tempo pieno

We aspire to be the premier research-intensive biopharmaceutical company in the world.
We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships.
Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases, such as HIV and Ebola, and emerging animal diseases.
Our purpose is to save and improve lives for generations.
Our strategy is simple: We follow the science.
The path to discovery is often unclear, but we are tireless in seeking solutions for some of the world's most difficult health challenges.
The roles of ACRM (Associate Clinical Research Manager) and CRM (Clinical Research Manager) are primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
**Responsibilities include, but are not limited to**:
- Main Point of Contact (POC) for assigned protocols and the link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance: trains in the protocol of other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
- Identifies and shares best practices across clinical trials, countries, and clusters.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent our company with investigators.
- Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
- Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH, and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, and Global Medical Affairs to align on key issues/decisions across the trials.
Consult with GHH as needed.
**Qualifications**
**Education and Minimum Requirements**:
- Bachelor's or advanced degree in science with some years of relevant work experience in clinical research.
**Required Experience and Skills**:
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
- Requires a strong understanding of the local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Experience functioning as a key link between Country Operations and Clinical Trial Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
- Proficiency in written and spoken English and Italian.
The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking.
- Ability to work efficiently in a remote and virtual environment.
- Understand cultural diversity.
- The position requires proven stron

  • Clinical Research Manager

    4 giorni fa

    Roma, Lazio, Italia Novo Nordisk A tempo pieno

    The Italian affiliate of Novo Nordisk, based in Rome, is hiring a Clinical Research Manager (CRA Team Manager).Do you want to join one of the leading companies of the pharma sector?Do you want to build your career and contribute to the growth and development of the company?We're on the lookout for a knowledgeable, proactive, dedicated people manager to lead...

  • Senior Clinical Research Manager

    1 settimana fa

    Roma, Lazio, Italia Ora A tempo pieno

    Company OverviewOra is a global leader in ophthalmic clinical research, guiding clients through all phases of clinical research to efficiently bring new products and therapies to market. Our expert teams have helped earn more than 85 new product approvals over the past 45 years.We are building the future of ophthalmic clinical research and creating vision...

  • Clinical Research Associate

    4 giorni fa

    Roma, Lazio, Italia Msd A tempo pieno

    Job SummaryThe Clinical Research Associate - Site Manager is accountable for the performance and compliance of assigned protocols and sites in a country.

  • Associate Clinical Research Manager

    3 settimane fa

    Roma, Lazio, Italia Msd A tempo pieno

    **Job Description**:We aspire to be the premier research-intensive biopharmaceutical company in the world.We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships.Today, we continue to be at the forefront of research to prevent and treat diseases that...

  • Clinical Research Associate

    5 giorni fa

    Roma, Lazio, Italia Msd A tempo pieno

    The role of Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements...

  • Clinical Research Associate

    2 settimane fa

    Roma, Lazio, Italia Msd A tempo pieno

    **Job Description**:The role is accountable for performance and compliance for assigned protocols and sites in acountry.Under the oversight of the CRA manager the person ensures compliance of study conduct withICH/GCP and country regulations, policies and procedures, quality standards andadverse event reporting requirements internally and externally.Acts as...

  • Clinical Research Associate

    2 settimane fa

    Roma, Lazio, Italia Msd A tempo pieno

    The Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Associate

    5 giorni fa

    Roma, Lazio, Italia Msd A tempo pieno

    **The role of **Clinical Research Associate** is accountable for performance and compliance for assigned protocols and sites in a country.**:**Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting...

  • Clinical Research Associate

    3 giorni fa

    Roma, Lazio, Italia CliniRx A tempo pieno

    CliniRx has a number of CRA positions available to support a global study in Q1 2025. We are expanding at a rapid rate and have multiple opportunities on a permanent basis to join us on a global study. Ideally, you will come from a CRO background with experience across multiple therapeutic areas. As a global contract research organization (CRO), we offer a...

  • Lead Clinical Research Associate

    3 settimane fa

    Roma, Lazio, Italia Ora A tempo pieno

    **POSITION TITLE**: Lead Clinical Research Associate**DEPARTMENT**: Ora Europe**LOCATIONS**:Poland, Spain or Italy**Ora Values the Daily Practice of **- Prioritizing Kindness- Operational Excellence- Cultivating Joy- Scientific Rigor_At Ora, we are building the future of ophthalmic clinical research.As the world's leading full-service ophthalmic drug and...

  • Clinical Research Associate Specialist

    1 settimana fa

    Roma, Lazio, Italia Sanaclis A tempo pieno

    We Are Seeking a Freelance CRA to Strengthen Our Clinical Operations in ItalyJob OverviewSanaclis is hiring a Part-Time Freelance Clinical Research Associate (CRA) to enhance our clinical operations in Italy. This role requires a strong understanding of clinical research processes, medical terminology, and regulatory requirements.Key ResponsibilitiesMonitor...

  • Freelance Clinical Research Associate

    2 settimane fa

    Roma, Lazio, Italia SanaClis A tempo pieno

    We are looking for a Part-Time Freelance CRA to strengthen our clinical operations in Italy. Preference will be given to candidates based in or around Rome, Pisa, Livorno, Grosseto , or Florence . Job Requirements: Bachelor's degree required – preferred qualification in life sciences or medical sciences Minimum 3 years of experience of onsite monitoring...

  • Freelance Clinical Research Associate

    3 giorni fa

    Roma, Lazio, Italia SanaClis A tempo pieno

    We are looking for aPart-Time Freelance CRAto strengthen our clinical operations inItaly.Preference will be given to candidates based in or aroundRome, Pisa, Livorno, Grosseto , orFlorence . Job Requirements: Bachelor's degree required – preferred qualification in life sciences or medical sciences Minimum 3 years of experience of onsite monitoring...

  • Freelance Clinical Research Associate

    1 giorno fa

    Roma, Lazio, Italia Sanaclis A tempo pieno

    We are looking for aPart-Time Freelance CRAto strengthen our clinical operations inItaly.Preference will be given to candidates based in or aroundRome, Pisa, Livorno, Grosseto , orFlorence .Job Requirements: Bachelor's degree required – preferred qualification in life sciences or medical sciences Minimum 3 years of experience of onsite monitoring...

  • Clinical Research Liaison

    7 giorni fa

    Roma, Lazio, Italia Warman O'Brien A tempo pieno

    Job OverviewWe are seeking a skilled Clinical Research Liaison to cover Central Italy, preferably based in Rome. This role involves engaging with key opinion leaders (KOLs) and contributing to advancements in infectious diseases specialty care.

  • Freelance Clinical Research Associate

    4 giorni fa

    Roma, Lazio, Italia JR Italy A tempo pieno

    Social network you want to login/join with: Freelance Clinical Research Associate, RomeClient:SanaClis Location:Rome, Italy Job Category:Other EU work permit required:Yes Job Reference:527449314114194636833710 Job Views:4 Posted:11.03.2025 Expiry Date:25.04.2025 Job Description:We Are Hiring We are looking for aPart-Time Freelance CRAto strengthen our...

  • Clinical Development Manager

    7 giorni fa

    Roma, Lazio, Italia Ollie Loveland A tempo pieno

    As a clinical development manager at our partner company, you will play a crucial role in shaping the future of biotechnology. You will oversee the planning, execution, and monitoring of clinical trials, ensuring compliance with regulatory requirements and industry standards.About the RoleThis position requires a highly organized and detail-oriented...

  • Freelance Clinical Research Associate

    3 settimane fa

    Roma, Lazio, Italia SanaClis A tempo pieno

    We Are Hiring We are looking for a Part-Time Freelance CRA to strengthen our clinical operations in Italy. Preference will be given to candidates based in or around Rome, Pisa, Livorno, Grosseto , or Florence . Job Requirements: Bachelor's degree required – preferred qualification in life sciences or medical sciences Minimum 3 years of...

  • FREELANCE Clinical Research Associate

    1 giorno fa

    Roma, Lazio, Italia SanaClis A tempo pieno

    We Are Hiring We are looking for a Part-Time Freelance CRA to strengthen our clinical operations in Italy. Preference will be given to candidates based in or around Rome, Pisa, Livorno, Grosseto , or Florence . Job Requirements: Bachelor's degree required – preferred qualification in life sciences or medical sciences Minimum 3 years of...

  • Position: Clinical Research Associate

    3 settimane fa

    Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno

    Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access.Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.Since 2008, Meditrial delivers unparalleled...