PRA Health Sciences

Site Activation Partner - Madrid

3 days left

Spain, Madrid
08 Feb 2021
10 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. Enter: the Strategic Solutions Division.

Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.

As a Site Activation Partner, you are responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and standards. 

The main responsibilities are:

  • Assist with study site activation activities to ensure timely site activation
  • Support and/or coordinate the whole regulatory submission process in collaboration with the investigator sites (confidentiality agreements, study contracts, clinical supply shipment information, payment information, etc.)
  • Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
  • Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
  • Support investigator sites and clinical operations team in preparation for and providing responses to site audits/inspections
  • Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation
  • Provide support with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and standards
  • In collaboration with other team members oversee site budget and contract negotiations, facilitate site payments, conduct remote monitoring activities
  • Provide other technical or logistical supportive activities that facilitate inspection readiness
  • In collaboration with other team members identify and resolve and investigator site issues within required time frames

You are:

Organised, creative and confident in taking independent action.

To ensure success within this role, the following are required:

  • Undergraduate degree or its international equivalent in clinical, science, or health related field
  • Minimum of 2 years of experience in start up/ regulatory in clincal trials
  • Experience with PC-Windows, word processing, and electronic spreadsheets required
  • Knowledge of ICH and local regulatory authority drug research and development regulations required
  • Clinical trials support or pharmaceutical industry experience required
  • Fluent in English and Spanish with effective verbal and written communication skills
  • Proven ability to work independently and also as a team member
  • Ability to organize tasks, time and priorities

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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