Site Activation Partner/Study Start Up Specialist - FSP

Parexel

$80K — $95K *
US-Anywhere
+ 4 other locationsRemote
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • School diploma/certificate with equivalent experience; BS/BA in life sciences preferred
  • Minimum 2 years in Clinical Trials and clinical site activation
  • Experience in pharmaceutical industry or CRO is a plus
  • Knowledge of clinical trial methodologies and ICH/GCP
  • Familiarity with FDA and local/national regulations
  • Fluency in local language and English; multi-language is beneficial

Responsibilities

  • Lead operational activities from start to close-out of assigned studies
  • Initiate and coordinate essential documents for Investigator Initiation Package
  • Support resolution of site issues and escalate as necessary
  • Manage coordination with supporting roles for timely site activation
  • Collaborate with regulatory groups and provide necessary documents
  • Maintain and update compliance tracking for clinical trial systems
  • Identify and address investigator site issues

Benefits

  • Comprehensive health insurance plans
  • Retirement savings plans
  • Professional development opportunities
  • Flexible working hours
  • Employee wellness programs
Full Job Description
The Site Activation Partneris 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 #LI-LO1

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