Match score not available

Site Activation Partner - FSP

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

School diploma/certificate with equivalent education, training, and experience; BS/BA in life sciences preferred., Minimum 2 years of relevant experience in Clinical Trials and clinical site activation., Knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations is essential., Fluency in the local language and English is required; multi-language capability is a plus..

Key responsabilities:

  • Lead or support operational activities from start-up to close-out for assigned studies and investigator sites.
  • Initiate and coordinate activities for the compilation of a high-quality Investigator Initiation Package (IIP).
  • Manage and coordinate with supporting roles to ensure timely site activation and operational activities.
  • Accurately update and maintain clinical trial systems that track site compliance and performance.

Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
See all jobs

Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Site Activation Partner I is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to: 

  • Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation   

  • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable 

  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities 

  • Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required 

  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines 

  • Identify and resolve investigator site issues 

Experience required for this role: 

  • School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred 

  • Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.  

  • Experience working in the pharmaceutical industry/or CRO is an asset 

  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations 

  • Must be fluent in Local language and in English. Multi-language capability is an asset 

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Collaboration
  • Communication
  • Problem Solving

Partner Related jobs