Pharma Point srl cerca CRA a Milano per una Prestigiosa Multinazionale Farmaceutica (contratto di 6 mesi)

July 18, 2014 by · Comments Off on Pharma Point srl cerca CRA a Milano per una Prestigiosa Multinazionale Farmaceutica (contratto di 6 mesi)
Filed under: Clinical Research 

Pharma Point srl Società di Ricerca e Selezione del personale per il settore Farmaceutico

www.pharmapoint.it

 

PharmaPoint

 

Prestigiosa Multinazionale Farmaceutica ci ha incaricati di ricercare un CRA da inserire con contratto di sei mesi (sede Milano sud).

Il nostro candidato ideale è laureato in Discipline Scientifiche in possesso di una esperienza pregressa nel ruolo (minimo 1 anni), maturate in contesti formativi.

 

Il CRA è la persona cui affidare il compito di organizzare, seguire e controllare l’andamento dello studio clinici presso il centro sperimentale. Il CRA quindi segue la sperimentazione, visitando i centri coinvolti nella

sperimentazione e collaborando con i medici impegnati nello studio.

 

Sarà responsabile di:

  • Rapportarsi con i Comitati Etici, sottomettendo il protocollo di ricerca clinica e tutti i documenti regolatori applicabili per la corretta gestione dello studio clinico.
  • collaborare nella selezione dei centri potenzialmente interessati a partecipare alla sperimentazione clinica (Pre Study)
  • Presentare il protocollo e le procedure studio specifiche agli sperimentatori, facendo loro il training richiesto per iniziare lo studio (Initiation Visit)
  • Monitorare lo studio clinico in tutte le sue fasi, recandosi anche presso il centro per effettuare le cosiddette Visite di Monitoraggio.
  • Archiviare la documentazione studio specifica in ufficio, ed assicurare il costante aggiornamento dei documenti conservati nel centro.
  • Assicurare il continuo rifornimento del materiale di sperimentazione al centro (sia esso farmaco o altro materiale di studio)
  • Occuparsi della Drug Accountability e dell’invio dell’IMP (Investigational Medicinal product) presso il dipartimento incaricato alla distruzione.
  • Chiudere i centri quando termina lo studio (Close-Out visit)

 

Requisiti indispensabili:

  • laurea in materie tecnico-scientifiche, Vecchio Ordinamento o Specialistica del nuovo ordinamento (Scienze naturali, Farmacia, CTF, Chimica, Biologia, Biotecnologie, Medicina ed altri corsi di laurea equipollenti)
  • ottima conoscenza della Lingua Inglese e pacchetto office
  • preferibilmente almeno 1 anno di esperienza maturata come CRA e in possesso della certificazione secondo il modello DM 15 Novembre 2011
  • Disponibilità a viaggiare in Italia e all’Estero
  • Sono inoltre richieste eccellenti abilità relazionali e comunicazionali, autonomia gestionale, problem solving e team-working.

 

Si offre:

  • Contratto ccnl Chimico Farmaceutico a tempo determinato (sei mesi)

 

Sede di lavoro:

  • Milano sud

 

Come presentarsi:

  • Scrivere a l.cavalieri [at]pharmapoint.it
  • Oggetto: CRAsecrets CRA per Farmaceutica

Quintiles cerca Global Regulatory & Start-Up Lead/Manager, based in EMEA (Rif. 1409334)

July 18, 2014 by · Comments Off on Quintiles cerca Global Regulatory & Start-Up Lead/Manager, based in EMEA (Rif. 1409334)
Filed under: Regulatory Affairs 

About Quintiles:

Quintiles logo

 

 

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

 

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.  To learn more about Quintiles, please visit www.quintiles.com

 

We continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We have a rewarding opportunity for a Global Regulatory & Start-Up Manager!

 

This is a global position and is flexible concerning the location.

 

PURPOSE
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities, oversight of the scope of work, budget and resources.

 

Responsibilities

  • The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
  • Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
  • Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
  • Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
  • Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
  • Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.
  • Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence.
  • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Work with Quality Management to ensure appropriate quality standards for the duration of the start up.
  • Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
  • Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
  • May take a proactive role in developing long standing relationships with preferred Quintiles customers.

Qualifications

 REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 

    • Good negotiating and communication skills with ability to challenge
    • Excellent interpersonal skills and strong team player; ability to co-ordinate and collaborate above, across and within complex projects.
    • Good regulatory and/or technical writing skills
    • Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
    • Ability to exercise independent judgment taking calculated risks when making decisions
    • Good leadership skills, with ability to motivate, coach and mentor
    • Good organizational and planning skills
    • Good presentation skills
    • Understanding of study financial management
    • Ability to establish and maintain effective working relationships with co-

workers, managers and sponsors.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in life sciences or related field with 7 years’ relevant experience including demonstrable experience in an international role; or equivalent combination of education, training and experience.

Primary Location

  • Great Britain

 

Other Locations

  • Italy, Spain, France, Germany, Netherlands

Organization

  • GBR02 – UK Product Development

How to apply

To apply for this job please visit the following URL:https://quintiles.taleo.net/careersection/10000/jobdetail.ftl

Quintiles cerca Senior CRA – home-based in Italy (GFR **-1410829)

July 18, 2014 by · Comments Off on Quintiles cerca Senior CRA – home-based in Italy (GFR **-1410829)
Filed under: Clinical Research 

About Quintiles:

Quintiles logo

 

 

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

 

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.  To learn more about Quintiles, please visit www.quintiles.com

 

Responsibilities 

Quintiles is looking for a SR CRA home based in Italy to join an huge project across the country. With the chance to work from our office in Milan or home based in Italy, as a CRA you will:

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.

Qualifications

 We are looking for dynamic people who enjoy communicating and interacting within teams, to achieve quality deliverables.

Successful candidates have the following requirements:

  • Bachelor’s degree in a health care or other scientific discipline
  • 2-4 years of monitoring experience.
  • Experience in Oncology will be positive considered
  • Fluent in English and Italian is a must.
  • Availability to travel

Primary Location

  • Italy

Organization

  • ITA02 – Italy Product Development

 

How to apply

To apply for this job please visit the following URL:https://quintiles.taleo.net/careersection/10000/jobdetail.ftl

Quintiles cerca CRA home based in Italy

July 18, 2014 by · Comments Off on Quintiles cerca CRA home based in Italy
Filed under: Clinical Research 

About Quintiles:

Quintiles logo

 

 

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

 

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.  To learn more about Quintiles, please visit www.quintiles.com

 

Responsibilities 

We are looking for enthusiatic people to join one of our Clinical Research Units. With the chance to work from our office in Milan or home based in Italy, as a CRA you will:

  • Monitor study progress to assure compliance with protocol-requirements, regulation and Good Clinical Practice by conducting site visits as directed
  • Participate in study development. Perform site selection, initiation, monitoring and close-out visits for a variety of protocols, sites and therapeutic areas
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
  • Conduct initial and ongoing site, sponsor, and project staff training as necessary. Establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Monitor study progress to assure compliance with protocol-requirements, regulation and Good Clinical Practice by conducting site visits as directed
  • Monitor and track patient enrollment and ensure the timely accurate and complete study data
  • Assist the Sponsor in problem solving and provide consultation on study related activities

Qualifications

 

  • Bachelor’s degree in a health care or other scientific discipline
  • 2-4 years of monitoring experience.
  • Fluent in English and Italian.
  • Availability to travel

Primary Location

  • Italy

Organization

  • ITA02 – Italy Product Development

Read more

Quintiles cerca Freelance Clinical Research Associate – Lombardia Italy

July 3, 2014 by · Comments Off on Quintiles cerca Freelance Clinical Research Associate – Lombardia Italy
Filed under: Clinical Research 

About Quintiles:

Quintiles logo

 

 

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

 

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.  To learn more about Quintiles, please visit www.quintiles.com

 

 

Key responsibilities of this role include:

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.  Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
  • May provide assistance to more less experienced clinical staff.

 

At Quintiles we value individuality, fresh ideas, and the contribution that our employees make to our success.  In return we offer career opportunities providing flexibility and growth across the organisation, competitive salary and benefits package, work-life balance initiatives and social events.  These are just some of the incentives we have to offer.

Read more

MedPace Italy cerca un Regulatory Submissions Coordinator con 2 anni di esperienza

June 16, 2014 by · Comments Off on MedPace Italy cerca un Regulatory Submissions Coordinator con 2 anni di esperienza
Filed under: Clinical Research, Regulatory Affairs 

MedPace Italy, CRO internazionale in forte espansione in Italia, sta cercando un Regulatory Submissione Coordinator.

Ecco la Job Description che puoi trovare direttamente sul sito web MedPace:

 

Location: Italy
Office: Office based, Milan
Full-time or Part-time: Full-time

DESCRIPTION OF JOB DUTIES

  • Prepare, review, submit and file clinical trial applications to national regulatory agencies;
  • Provide updated forecast of local submission and approval timelines;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Collect the required investigator and regulatory documents from the sites ensuring documents meet the required specifications
  • Interact with contracts lead to negotiate and execute site-specific country template contract
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise study team on changing regulations and compliance requirements; and
  • Track submissions and ensure timely filing of documents.

QUALIFICATIONS/REQUIREMENTS

  • Bachelor’s degree in life sciences;
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation and contracts;
  • At least two years of startup experience as a Regulatory Submissions Coordinator;
  • Excellent organization and communication skills;
  • Knowledge of Microsoft® Office;
  • Fluency in English and local language.

 

WHAT TO EXPECT NEXT
We look forward to receiving your application in english. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

 

HOW TO APPLY

To apply please access our career opportunities on our website at: www.medpace.com and apply for this position through our system by uploading your CV in English. A member of our recruitment team

will review your qualifications. If interested, you will be contacted for an interview.

For more information please visit our website: www.medpace.com

 

 

 

Applica ora per unirti al team MedPace Italy!

Keyrus Biopharma: Home based Clinical Research Associate in Italy

February 21, 2014 by · Comments Off on Keyrus Biopharma: Home based Clinical Research Associate in Italy
Filed under: Clinical Research 
As a Contract Research Organisation (CRO) and major player in clinical research, Keyrus Biopharma has been has been sharing its clinical research experience with pharmaceutical industries, food industries and biotech
companies in the development of drugs and other products such as nutritional products, medical devices, cosmetics and contrast products. Our headquarters are based in France.
Today, Keyrus Biopharma provides expertise and consultancy in all clinical research areas (monitoring, data management, biostatistics, medical writing…), and is recognized by our clients in France and abroad.
We are looking for an Experienced Clinical Research Associate in Italy, to work Home Based: Organized, with good communication skills, fluent in Spanish and English, with Life science education
(biomedical sciences, pharmacy, biology, nursing or similar) and previous experience as a CRA, your main Read more

Contract Negotiator, sixt months contract – full time

November 30, 2013 by · Comments Off on Contract Negotiator, sixt months contract – full time
Filed under: Clinical Research 

DOCS – a leading provider of global resourcing solutions to the Drug Development industry- is recruiting!

Excellent opportunity for an experienced Contract Negotiator, Home/Office  based, to work for a Pharmaceutical Company.

The role is Temporary, 6 months contract, full time.

Contract Negotiator Position:

Responsibilities:

  • Prepare study-specific Clinical Trial Agreements templates with investigators and
  • Negotiate budget costs and contract language with the appropriate party at the sites Read more

Freelance Clinical Research Associate Medical Device a Milano

September 9, 2013 by · Comments Off on Freelance Clinical Research Associate Medical Device a Milano
Filed under: Clinical Research 

 

St. Jude Medical Italia – Multinazionale Americana leader nella produzione di dispositivi medicali – ricerca in area Milano un CLINICAL RESEARCH ASSOCIATE FREELANCE per importante studio clinico da effettuare.

Il candidato che cerchiamo ha maturato un’esperienza di almeno 3 anni negli Studi Clinici di aziende del Medical Device ed è autunomo nella verifica della documentazione del centro in base al piano di monitoraggio e rispetto ai dati riportati nei CRF.

É richiesta un’ottima conoscenza della lingua inglese orale e scritta per potersi interfacciare efficacemente con l’Head Quarter. Costituisce requisito preferenziale la certificazione Read more

Clinical Research Associate II with 3+ years for international CRO

September 8, 2013 by · Comments Off on Clinical Research Associate II with 3+ years for international CRO
Filed under: Clinical Research 

International CRO:
We offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span
the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

Job Title:
CRA II office based in Rome or home-based

Job description:
Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Responsibilities:

Tasks may include but are not limited to:

  • Perform feasibility studies for potential sites as requested
  • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.) Read more

Next Page »