Clinical Research Site Monitor
2 settimane fa
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP is currently seeking Site Monitors I/II in any location in Italy. As a Site Monitor, you would focus on monitoring at maintenance phase almost exclusively. You would be dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases. Our sponsor has a long history of excellence in research, delivering medicines, vaccines, and other health solutions for some of the most difficult diseases in the world. Key Accountabilities Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations Conducts source document review and verification of appropriate site source documents and medical records Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete Manages reporting of protocol deviations and appropriate follow up Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP Conducts follow up for escalated adverse event monitoring (AEM) report queries Collaborates with primary Site Manager who will act as the primary liaison with site personnel The Individual A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite) Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice Proficiency in local language is required English proficiency is required Ability to manage required travel of on a regular basis Skills Networking and relationship building skills Ability to communicate effectively and appropriately with internal and external stakeholders Ability to adapt to changing technologies and processes Effectively overcoming barriers encountered during the implementation of new processes and systems Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization Identifies and builds effective relationships with investigator site staff and other stakeholders Must demonstrate good computer skills and be able to embrace new technologies #LI-REMOTE #J-18808-Ljbffr
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Clinical Research Associate, Site Management
6 giorni fa
Roma, Italia IQVIA LLC A tempo pienoClinical Research Associate, Site Management - Italy page is loaded Clinical Research Associate, Site Management - Italy Apply locations Milan, Italy time type Full time posted on Posted Yesterday job requisition id R1415148 Job Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring...
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Clinical Research Associate, Italy
4 settimane fa
Roma, Italia EastHORN Clinical Services A tempo pieno**Job summary**: As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties....
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Clinical Research Associate Ii
4 settimane fa
Roma, Italia ABBVIE A tempo pieno**Key responsibilities**: - Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring...
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Clinical Research Associate III
6 giorni fa
Roma, Italia Barrington James A tempo pienoClinical Research Associate III - Ophthamology - Italy Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable...
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Clinical Research Associate II
7 giorni fa
Roma, Italia Barrington James A tempo pienoClinical Research Associate II - Ophthamology - Italy Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable...
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Clinical Research Manager
6 giorni fa
Roma, Italia Novo Nordisk A tempo pienoThe 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...
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Clinical Research Manager
7 giorni fa
Roma, Italia Fortrea A tempo pienoClinical Research Manager - Home Based Italy As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20...
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Clinical Research Associate
2 settimane fa
Roma, Italia Optimapharm A tempo pienoLocation: home-based Who are we? Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations. With 27 strategically located offices , Optimapharm operates in 40+...
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Clinical Specialist
7 giorni fa
Roma, Italia Masimo A tempo pienoCentral Italy**Job Summary**: The Clinical Specialist is an entry level role responsible for supporting Masimo Products and maintaining customer relationships with a variety of clinicians and other key stakeholders. **Duties & Responsibilities**: - You will be seen as an expert in pulse oximetry and pulse CO-Oximetry as well as an authority on the clinical...
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Clinical Specialist
2 settimane fa
Roma, Italia Masimo Corporation A tempo pienoCentral Italy Job Summary: The Clinical Specialist is an entry level role responsible for supporting Masimo Products and maintaining customer relationships with a variety of clinicians and other key stakeholders. Duties & Responsibilities: You will be seen as an expert in pulse oximetry and pulse CO-Oximetry as well as an authority on the clinical impact...
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Site Manager
2 settimane fa
Roma, Lazio, Italia Johnson & Johnson A tempo pienoJohnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure...
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Global Clinical Start up Manager Italy
2 settimane fa
Roma, Italia Resourcing Life Science A tempo pienoCompany Description Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager home based in Italy. Job Overview Leading cross-functional project...
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Senior CRA
2 settimane fa
Roma, Italia Barrington James Limited A tempo pienoBarrington James is actively recruiting for a challenging role as a Clinical Research Associate (CRA II). As part of our clients in-house team, you will be responsible for site management, encompassing start-up activities both on-site and remotely across Italy. This role involves working on diverse projects from our client base, which includes small to...
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Principal Clinical Trial Manager
4 giorni fa
Roma, Italia Syneos Health A tempo pienoPrincipal Clinical Trial Manager - Oncology or Ophtalmology experience required Description Principal Clinical Trial Manager - Oncology or Ophtlamology experience required Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial...
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Senior Clinical Trial Manager
4 giorni fa
Roma, Italia ICON A tempo pienoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Clinical Innovation
1 ora fa
Roma, Italia Novo Nordisk A tempo pienoClinical Innovation & Implementation Manager **Category**:Clinical Development**Location**:Roma, Lazio, IT- **The Position** - As our Innovation and Implementation Manager, you will be responsible for leading and implementing innovative clinical projects, as well as tracking and analysing clinical activities throughout CDC Italy, with the aim of maximizing...
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Senior Research Analyst
2 settimane fa
Roma, Italia Pzena Investment Management LLC A tempo pienoConduct rigorous, in-depth analysis on potential new investments for the firm through industry research, review of public filings, and meetings with senior management. Work with internal colleagues and outside experts on new investment research, setting the direction and proposed workplans for this research. Perform value-oriented fundamental equities...
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Ssu Regulatory Coordinator/contracts Management
6 giorni fa
Roma, Italia Syneos Health Clinical A tempo pieno**Description** **Site Start-Up Regulatory Coordinator (Sponsor dedicated)** **Location: please note that the job role is hybrid - the employee will be required to spend 2-3 days in the office in Campo Verde** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a...
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Ssu Regulatory Coordinator/contracts Management
4 settimane fa
Roma, Italia Syneos Health Clinical A tempo pieno**Description** **Site Start-Up Regulatory Coordinator (Sponsor dedicated)** **Location**: **1. Italy - please note that the job role is hybrid - the employee will be required to spend 2-3 days in the office in Campo Verde** **or** **2. Serbia** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to...
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Regulatory and Site Readiness Specialist Ii
6 giorni fa
Roma, Italia Labcorp A tempo pienoWe are seeking a Study Start Up Specialist to be responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient...