Site Activation Specialist

Job Responsibilities:

• Accountable for timely start-up activities from country allocation until site greenlight at assigned sites

• Conducts site selection visits, verifies site eligibility for a specific study 

• Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation

• Ensures that milestones (KPIs) and time schedule for study start-up are met as planned

• Facilitates the preparation and collection of site and country level documents 

• Collects submission-related site-specific documents for all relevant site personnel within agreed timelines

• Supports the Site Activation Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
  Supports the Site Activation Manager and assigned sites with vendor set-up activities

• Prepares and finalizes site specific documents for submission

• Negotiates investigator payments, as needed

• Supports preparation of financial contracts between sponsor and investigational sites and investigators, as needed

• Updates all systems on an ongoing basis

• Supports preparation of audits and inspections, as applicable

• Supports reduction of formal site-specific IRB/IEC deficiencies 

• Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness

• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

• Implements innovative and efficient processes which are aligned with the sponsor's strategy

Job Requirements:

• Min. 1 year of relevant experience

• Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or relevant experience in clinical start-up activities

• In-depth knowledge of clinical systems, procedures, and corporate standards.

• Good negotiating and communication skills with ability to challenge, if applicable.

• Effective communication, organizational, and interpersonal skills.

• Ability to work independently and to effectively prioritize tasks.

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.

• Understanding of regulated clinical trial environment and knowledge of drug development process.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

#LI-Hybrid

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com