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Job Details

Clinical Research Associate, Start Up-152209

Company: PPD
Location: Europe, Middle East & Africa-Netherlands-Gelderlan
Reference: 152209
Closing Date: 14 Jan 19
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

About PPD   PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...

Requirements:

About PPD

 

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.

 

This is a great time to join PPD in the Netherlands. We are currently recruiting for Clinical Research Associates to join our Site Intelligence & Activation (SIA) department (Start Up). Our goal-driven teams combine and deliver study start-up activities for clinical trials collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start-up timelines and exceed expectations.

PPD Netherlands is located in a beautiful old building in the surroundings of Bennekom. We are a team of 150 people, that work very closely together and also enjoy participating in the monthly activities organized by our social committee.


Essential Functions and Other Job Information


  • Provides Site Selection support for awarded multi-service projects
  • Conducting the Site Selection assessments locally via communication with investigators. Conduct of country- and site-level feasibility.
  • Conduct pre-study visits (PSVs), prepare PSV-reports, and provide information leading to a decision to render the site qualified or not qualified for participation in the trial.
  • Key-contact at country level for either Ethical or Regulatory submission-related activities. Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
  • Achieves PPD’s target cycle times for site
  • Develop and implement the local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments to ensure all site start-up activities are aligned with submission activities and mutually agreed upon timelines.
  • Prepare, review and coordinate the local regulatory submissions (MoH, EC, additional special national local applications if applicable, import licenses etc) in alignment with the global submission strategy.
  • Develop country and site specific Patient Information Sheet/Informed Consent form and other patient related documents as applicable.
  • Ensure the submission process for sites and studies are aligned to the critical path for site activation.
  • Developed collaborative relationships with investigative sites and client company personnel.
  • Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients,
  • Collection of CDA/DPA/IBI from the site, distribution of electronic (in some cases paper) feasibility to sites, CTMS entry and tracking of all Site Interest Plan documentation and associated communications; facilitation of information to the GIS representative for site creation in CTMS.
  • Negotiate and finalize site contracts and budgets as necessary
  • Maintain regular site contact during the start-up phase and document all communications in CTMS.
  • Collect and QC’s all trial commencement documents including essential (RCR) and non- essential (non RCR) documents and certifications. 

#LI-NL1 IndeedPPDEMEA1

Qualifications

Education and Experience

Bachelor's degree or above

Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

Knowledge, Skills And Abilities


  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Strong attention to detail and quality of documentation
  • Good negotiation skills
  • Good computer skills and the ability to learn appropriate software
  • Good English language and grammar skills
  • Basic medical/therapeutic area and medical terminology knowledge
  • Ability to work in a team environment or independently, under direction as required
  • Basic organizational and planning skills
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

In return, we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are truly recognised as the cornerstone of our success. We will provide you with meaningful and challenging work and the opportunity to acquire valuable personal and professional skills; through our best in class training and development. 

 

We encourage you to visit our website, http://www.ppdi.com/ and the careers section, to view our Life at PPD blog, which will give you an insight of what it is like working within one of the largest CROs in the world.


Apply for this job: Clinical Research Associate, Start Up-152209

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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