Clinical Start Up Specialist, Cdc Poland
2 settimane fa
**The Position**
Your main accountabilities will be to:
- Manage and execute the start-up activities in the allocated clinical trial in compliance with EU CTR, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements
- Manage ongoing trials - performing submissions (including translation/redaction of documents), CONNECT, RIM, COSMOS updates
- Prepare Part II and selected Part I documents for submission (including translation and redaction) and to handover the CTA package to EU submission HUB within selected timelines - completion of EMA templates, obtain local insurance certificate
- Check the completeness and correctness of all documents/materials for SIV in close collaboration with the CRA and CDC Clinical Trial Administrator
- Participate in kick-off meetings and trial TCs with the EU submission Hub and CDC Clinical Start Up Trial Managers
**Qualifications**
To be effective in this role we need you to have min. 2 years of experience in clinical operations start-up and submissions. Along with fluent English and Italian language skills.
Other requirements:
- The ability to build and maintain strong working relationships with internal and external stakeholders
- A team-oriented personality with high degree of flexibility - close collaboration with relevant roles to ensure successful start-up of the trial
- High result orienting in driving of start-up milestones according to CDC start-up KPIs
- Ability and willingness to adjust quickly to new situations in a continuously developing environment
- A high degree of trustworthiness, proven decision making and problem-solving capabilities, and a high focus on delivery and quality
**About the Department**
CDC Poland is part of Region South-East Europe, Middle East and Africa (SEEMEA) and is a new set up of clinical organization in Novo Nordisk Poland, covering a group of 16 countries including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, North Macedonia, Italy, Romania, Serbia, Slovakia, Slovenia and Poland. CDC Poland is responsible for conducting clinical trials across this group of countries, providing clinical trial management and administration support to adjacent Affiliates. CDC Poland is currently responsible for approximately 20% of global patients in Novo Nordisk clinical trials.
**Working at Novo Nordisk**
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease
**Contact**
**Deadline**
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
-
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...
-
Study Start Up Specialist
4 settimane fa
Roma, Italia TFS HealthScience A tempo pienoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a Study Start Up Specialist** **About...
-
Clinical Innovation
3 ore 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...
-
Study Start Up and Regulatory Affairs Specialist
4 settimane fa
Roma, Italia Ergomed A tempo pienoCompany Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...
-
Regulatory Specialist, Italy
4 settimane fa
Roma, Italia EastHORN Clinical Services A tempo pieno**Job summary**: As a **Regulatory Specialist **you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in Italy. Reporting to **Clinical Operations Manager**, you will...
-
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...
-
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...
-
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...
-
Clinical Education Specialist Radiologia
4 settimane fa
Roma, Italia Kelly Services A tempo pieno**Dettagli** **Pubblicazione** - 19-04-2023**Retribuzione** **Località** - Roma**Tipologia** - Somministrazione**Settore** - Scientifico e Farmaceutico**Referenze** - BBBH603122**Descrizione dell'offerta** Kelly Science & Clinical, per multinazionale leader nel settore diagnostica, ricerca un: **CLINICAL EDUCATION SPECIALIST RADIOLOGIA** La risorsa...
-
Customer Service Specialist
3 settimane fa
Roma, Italia Zentiva Poland A tempo pienoCustomer Service Specialist page is loaded Customer Service Specialist Postuler locations Italy / Milano time type Temps plein posted on Offre publiée il y a 2 jours job requisition id R2465817 Zentiva Italia è un'azienda in forte espansione, che può offrire un'intensa esperienza di crescita professionale in un contesto giovane, dinamico, flessibile e con...
-
Clinical Specialist
4 settimane fa
Roma, Italia Johnson & Johnson A tempo pienoJOHNSON & JOHNSON MedTech “ **Caring for the world**one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to...
-
.Net Developer
1 settimana fa
Roma, Italia Michael Page International Italia S.r.l. A tempo pienoAzienda Il cliente è una start-up innovativa che offre servizi di consulenza e strumenti digitali per la misurazione, valorizzazione e gestione dell'impatto di un azienda. Job Description Il candidato sarà inserito all'interno del team di sviluppo e parteciperà a progetti di implementazione della piattaforma digitale proprietaria dell'azienda. Competenze...
-
Accounting Specialist
4 settimane fa
Roma, Italia Zentiva Poland A tempo pienoZentiva Italia è un'azienda in forte espansione, che può offrire un'intensa esperienza di crescita professionale in un contesto giovane, dinamico, flessibile e con una chiara e forte visione di sviluppo strategico e commerciale. Ci prendiamo cura delle nostre persone, offrendo loro uno stimolante contesto lavorativo, che include, tra l'altro, smartworking,...
-
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...
-
.Net Developer
2 settimane fa
Roma, Italia Michael Page International Italia S.r.l. A tempo pienoAzienda Il cliente è una start-up innovativa che offre servizi di consulenza e strumenti digitali per la misurazione, valorizzazione e gestione dell'impatto di un azienda. Job Description Il candidato sarà inserito all'interno del team di sviluppo e parteciperà a progetti di implementazione della piattaforma digitale proprietaria...
-
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...
-
JM-62 - Inside Sales- Start Up, Disponibilità Immediata
2 settimane fa
Roma, Lazio, Italia Confidenziale A tempo pienoCategoria: Technology & TelecomsLuogo di lavoro: Milano e provinciaPer nota Start up in ambito della formazione personalizzata, cerchiamo delle figure di Inside Sales, possibilmente con disponibilità immediata, da inserire in un contesto dinamico e giovanile.Il/ la professionista avrà le seguenti responsabilità: Rispetto dei KPI assegnatiGestione delle...
-
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...
-
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...
-
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...