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!

Clinical Research Associate, Milano Office Based

January 25, 2013 by · Comments Off on Clinical Research Associate, Milano Office Based
Filed under: Clinical Research 

Clinical Research Associate, Milano Office Based

Sono alla ricerca di un monitor per una delle CRO piu’ importanti del Mondo, per una posizione a tempo indeterminato Office Based a Milano.
Il candidato ideale risponde ai seguenti requisiti:
*Certificazione DM 2008 e successive modifiche;
*Esperienza di almeno 18 mesi monitorando autonomamente centri in tutta Italia;
*Esperienza su clinical trials interventistici di fase II-IV;
*Motivazione al cambiamento e a lavorare a Milano Office Based.
Il mio cliente offre uno dei training migliori del settore, eccellente trattamento contrattuale e un pacchetto retributivo tra i piu’ competitivi. Ottime possibilita’ di carriera future.
Se interessati inviare un CV a sergio.carito@secpharma.com
Sentitevi liberi di passare la parola e i miei contatti a quanti potrebbero beneficiare di questa ottima opportunita’.

Sergio Carito
Consultant Biotech, Pharmaceutical, Healthcare & CRO Division
Italy and Europe
Tel: +44 (0) 207 255 6665
sergio.carito@secpharma.com
http://uk.linkedin.com/in/sergiocarito

Senior Clinical Research Associate – Per un 2013 di successo

December 21, 2012 by · Comments Off on Senior Clinical Research Associate – Per un 2013 di successo
Filed under: Clinical Research 

Senior CRA Italy

Milan Office Based or Home based available

Global CRO is seeking a talented Senior CRA with at least 4 years of solid experience in monitoring activities to join them on a permanent basis. You will be in charge of the monitoring activities, ensuring and assuring the quality of the data collected on site according to ICH-GCP, SOP and study protocol. You will have responsibilities of Site Management, identifying, selecting, initiating and closing-out investigational sites and acting as liaison between study site and in-house team. You will also be in charge of the Study Management, working independently and proactively to coordinate all necessary activities required to set up and monitor a study.

Qualifications:

* University Life Science Degree

* D.M. 2011 Certification

* Experience as CRA in phase II – IV

* In depth knowledge of ICH-GCP, EU and FDA requirements

* Excellent Italian and English language skills (spoken and written)

* Willingness & ability to travel (approx. 50%)

* Teamwork

My Client can offer a competitive salary and benefits package, the best training in the industry and will support individual as well professional development in one of the most important global companies in the Clinical Research.

To apply, forward your CV to Sergio.carito@secpharma.com call Sergio Carito on + 44(0)207 255 66 00 for further information and a confidential discussion of this opportunity.

Sergio Carito

Consultant Biotech, Pharmaceutical, Healthcare & CRO Division

Italy and Europe

Tel: +44 (0) 207 255 6665

sergio.carito@secpharma.com http://uk.linkedin.com/in/sergiocarito

CRA II – Inizia il 2013 con un Top Employer

December 21, 2012 by · Comments Off on CRA II – Inizia il 2013 con un Top Employer
Filed under: Clinical Research 

CRA II

Permanent role

Milano Office based

CRO Globale tra le Top 5 nel Mondo cerca un Clinical Research Associate II per viaggiare su tutta Italia e gestire i monitoraggi secondo ICH GCP, FDA guidelines e SOPs globali. In questo ruolo si ha la opportunità di occuparsi della gestione a 360 gradi di un clinical trial, con il supporto dei team dedicati nelle fasi di start up e per la documentazione necessaria.

Le candidature verranno tenute in considerazione a partire da gennaio 2013.

Esperienza:

o Idealmente 18 mesi/3 anni come Clinical Research Associate

o Idealmente esperienza in fasi II – IV

o Avere reali competenze in inglese, a livello di comprensione e espressione orale e scritta

o Doti comunicative, di presentazione, teamwork, autonomia e precisione

o Compliant con D.M. 2011 Certification

Questa è una opportunità ideale per un professionista organizzato e tecnicamente molto preparato. Si offre training e sviluppo continuo, ambiente di lavoro amichevole e internazionale, un percorso di carriera sicuro e programmato e un pacchetto retributivo molto competitivo.

Se interessati, spedire il CV a Sergio.carito@secpharma.com, +44 (0)207 255 6665.

Sergio Carito

Consultant Biotech, Pharmaceutical, Healthcare & CRO Division

Italy and Europe

Tel: +44 (0) 207 255 6665

sergio.carito@secpharma.com

http://uk.linkedin.com/in/sergiocarito

CRA II – Cambia per il meglio

December 21, 2012 by · Comments Off on CRA II – Cambia per il meglio
Filed under: Clinical Research 

CRA II – Cambia per il meglio nel settore

Permanent Multiple Positions

Milano Office based o Home based da Locations ben connesse

Lavoro per una delle CRO più prestigiose al mondo cercando dei Clinical Research Associate II per viaggiare nationwide e gestire i monitoraggi secondo ICH GCP, FDA guidelines e SOPs globali. Dopo un breve periodo in ufficio a Milano per i training, si ha la possibilità di lavorare da casa.

Le candidature verranno tenute in considerazione a partire da gennaio 2013.

Esperienza:

o Idealmente 18 mesi/3 anni come Clinical Research Associate

o Idealmente esperienza in fasi II – III

o Avere reali competenze in inglese, a livello di comprensione e espressione orale e scritta

o Doti comunicative, di presentazione, teamwork

o Compliant con D.M. 2011 Certification

Questa è una opportunità ideale per un professionista organizzato e tecnicamente molto preparato. Si offre training e sviluppo continuo, ambiente di lavoro amichevole e internazionale, un percorso di carriera sicuro e programmato e un pacchetto retributivo molto competitivo.

Se interessati, spedire il CV a Sergio.carito@secpharma.com, +44 (0)207 255 6665.

Sergio Carito

Consultant Biotech, Pharmaceutical, Healthcare & CRO Division

Italy and Europe

Tel: +44 (0) 207 255 6665

sergio.carito@secpharma.com

http://uk.linkedin.com/in/sergiocarito

Senior Monitor Italy – Top Class Employer

November 23, 2012 by · Comments Off on Senior Monitor Italy – Top Class Employer
Filed under: Clinical Research, Miscellaneous 

Senior Monitor Italy
Office Based or Home based available

Top Global Contract Research Organization is seeking talented Senior CRAs with at least 3 years of solid experience to join them on a permanent basis.
You will be in charge of the monitoring activities, ensuring and assuring the quality of the data collected on site according to ICH-GCP, SOP and study protocol. You will have responsibilities of Site Management, identifying, selecting, initiating and closing-out investigational sites and acting as liaison between study site and in-house team. You will also be in charge of the Study Management, working independently and proactively to coordinate all necessary activities required to set up and monitor a study.
Qualifications:
* University Life Science Degree
* D.M. 2011 Certification
* Experience as CRA in phase II – IV
* In depth knowledge of ICH-GCP, EU and FDA requirements
* Excellent Italian and English language skills (spoken and written)
* Willingness & ability to travel (approx. 50%)
* Teamwork

My Client can offer a competitive salary and benefits package, the best training in the industry and will support individual as well professional development in one of the most important global companies in the Clinical Research.

To apply, forward your CV to Sergio.carito@secpharma.com
Call Sergio Carito on + 44(0)207 255 66 00 for further information and a confidential discussion of this opportunity.

Sergio Carito
Consultant Biotech, Pharmaceutical, Healthcare & CRO Division
Italy and Europe
Tel: +44 (0) 207 255 6665
sergio.carito@secpharma.com
http://uk.linkedin.com/in/sergiocarito

Project Assistant Categorie Protette

November 5, 2012 by · Comments Off on Project Assistant Categorie Protette
Filed under: Clinical Research, Miscellaneous, Regulatory Affairs, Uncategorized 

Project Assistant Categorie Protette

 

Una delle migliori CRO Globali sta cercando un Project Assistant a tempo indeterminato office based nei loro uffici di Milano, per supporto amministrativo ai progetti di clinical research.

 

La persona ricercata appartiene alle categorie protette e ha eccellenti doti comunicative, organizzative, e’ motivato/a, flessibile e un approccio professionale.

 

Responsabilita’:

1) Fornire supporto amministrativo generale a tutti i membri dei Team di progetto.

2) Mantenere project files e documentazione in ordine.

3) Coordinare i viaggi dei membri del Team

4) Assistere nella organizzazione dei meetings.

5) Mantenere i database.

6) Altri compiti ad-hoc associati alla gestione dei clinical trials e office administration dove richiesto.

 

Il candidato ideale ha ottime competenze informatiche, incluso Microsoft Office. E’ una persona motivata e con attitudine positiva, con doti comunicative e interpersonali eccellenti. Il candidato ideale ha anche forti doti organizzative e attenzione ai dettagli, e’ multitasking e sa lavorare autonomamante e in team.

E’ richiesta la fluenza in Italiano e in Inglese.

 

La ricerca e’ riservata ai soli iscritti alle categorie protette ai sensi della legge 68/99.

Vi prego di inviare un cv aggiornato a sergio.carito@secpharma.com.

Vi prego di far girare questo annuncio per dare una ottima opportunita’ di lavoro a quanti conoscete che siano in linea con il profilo e ne possano beneficiare.

 

Sergio Carito

Consultant Pharmaceutical, CRO, Healthcare & Biotech Division

Italy and Europe

Tel: +44 (0) 207 255 6665

sergio.carito@secpharma.com

http://uk.linkedin.com/in/sergiocarito

 

SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business

Senior CRA – TOP Global CRO

September 7, 2012 by · Comments Off on Senior CRA – TOP Global CRO
Filed under: Clinical Research 

Senior CRA Italy
Milan Office Based or Home based available

Leading global pharmaceutical service provider is looking for experienced Clinical Research Associates with at least 3 to 5 years of experience in monitoring to join their Clinical Development Department on a permanent basis to provide high quality service to the sites and to the best international sponsors.
You will be in charge of the monitoring activities, ensuring and assuring the quality of the data collected on site according to ICH-GCP, SOP and study protocol. You will have responsibilities of Site Management, identifying, selecting, initiating and closing-out investigational sites and acting as liaison between study site and in-house team. You will also be in charge of the Study Management, working independently and proactively to coordinate all necessary activities required to set up and monitor a study.
Qualifications:
* University degree in a science related field or certified health care professional or equivalent experience
* D.M. 2011 Certification
* Experience as CRA in clinical development phase II – IV
* In depth knowledge of ICH-GCP, EU and FDA requirements
* Excellent Italian and English language skills (spoken and written)
* Willingness & ability to travel (approx. 50%)
* Capability to work in a team
My Client can offer a competitive salary and benefits package and will support individual as well as professional development in one of the most important global companies in the Industry.
To apply, forward your CV to Sergio.carito@secpharma.com
Call Sergio Carito on + 44(0)207 255 66 00 for further information and a confidential discussion of this opportunity.
Sergio Carito
Consultant Biotech, Pharmaceutical, Healthcare & CRO Division
Italy and Europe
Tel: +44 (0) 207 255 6665
sergio.carito@secpharma.com
http://uk.linkedin.com/in/sergiocarito

CRA II – Office based a Milano

September 7, 2012 by · Comments Off on CRA II – Office based a Milano
Filed under: Clinical Research 

Clinical Research Associates II
Permanent Multiple Positions
Office based in Milan

Clinical Research Organisation globale basata a Milano sta cercando dei Clinical Research Associates II per viaggiare nationwide e gestire i monitoraggi secondo ICH GCP, FDA guidelines e SOPs globali.

Esperienza:
o Idealmente 18 mesi/3 anni come Clinical Research Associate
o Idealmente esperienza in fasi II – III
o Avere reali competenze in inglese, a livello di comprensione e espressione orale e scritta
o Doti comunicative, di presentazione, teamwork
o Compliant con D.M. 2011 Certification

Questa è una opportunità speciale, che offre training e sviluppo continuo, ambiente di lavoro amichevole e internazionale, progressione di carriera e un pacchetto retributivo molto competitivo.
Se interessati, spedire il CV a Sergio.carito@secpharma.com, +44 (0)207 255 6665.
Sergio Carito
Consultant Biotech, Pharmaceutical, Healthcare & CRO Division
Italy and Europe
Tel: +44 (0) 207 255 6665
sergio.carito@secpharma.com
http://uk.linkedin.com/in/sergiocarito

Clinical Research Associate Trainee – office based at Quintiles Milano – fixed term contract – Rif.1114471

August 28, 2012 by · Comments Off on Clinical Research Associate Trainee – office based at Quintiles Milano – fixed term contract – Rif.1114471
Filed under: Clinical Research 

POSIZIONE TEMPORANEAMENTE SOSPESA

Direttamente dal sito web di Quintiles.com

QUINTILES, leader indiscusso nella fornitura di servizi all’industria farmaceutica e biotecnologica,  è lieto di offrire

Il 4° MASTER aziendale in Ricerca Clinica

Stiamo selezionando 15 partecipanti per proporre loro 10 giorni d’aula, intensivi, che porteranno 6 di loro ad avere l’opportunità di uno stage di 3 mesi all’interno delle Clinical Operations di Quintiles, arrivando così ad ottenere la certificazione prevista dal DM del 31 Marzo 2008 per la  figura di Clinical Research Associate. Read more

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