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

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