Spécialiste en affaires réglementaires et en démarrage 2 / Regulatory & Start-Up Specialist 2 Bilingual at IQVIA

Kirkland, Quebec, Canada

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

Bilingual (French and English)
In-depth knowledge of current regulations and industry trends related to site feasibility
Ability to conduct research and data analysis to identify potential sites meeting study criteria and objectives
Proficiency in clinical systems and providing support to users, including receiving, evaluating, and recommending on issues or improvements
Effective communication skills with study teams and stakeholders
Ability to work under general supervision

Responsibilities

Act as the main point of contact (SPOC) for assigned study sites, Site Activation Managers (SAM), project management team, and other services as needed
Ensure compliance with standard operating procedures (SOPs), work instructions, quality of designated deliverables, and project timelines
Support site identification and feasibility under the direction of the global site identification and feasibility manager or lead specialist, including system setup, feasibility questionnaire creation, and distribution
Track and enter feasibility response data, report responses to internal stakeholders
Resolve any issues or discrepancies in the feasibility process (internal studies and/or outsourced)
Support enrollment forecasting and discuss scenarios with internal or external stakeholders under supervision
Perform site activation activities in compliance with applicable regulations, SOPs, and work directives; transmit completed documents to sites and internal project team members
Prepare site regulatory documents, verifying their completeness and accuracy
Ensure accurate entry and updates in internal systems, databases, and tracking tools with project-specific information
Analyze site performance indicators and report observations to management
Review, establish, and validate project planning and timelines; ensure tracking measures are in place and implement contingency plans as needed
Inform team members of the completion of regulatory and contractual documents for each site
Review, track, and follow up on progress, approval, and execution of regulatory, ethical documents, informed consent forms (ICFs), and investigator dossier (ID) distribution documents per project timelines
Provide local expertise to SAMs and project team throughout initial planning and ongoing activities
Perform national-level tasks related to site activation (SA) activities, in compliance with local/international regulations, SOPs, project requirements, and contractual/budgetary directives (may include maintenance activities)

Skills

Regulatory Affairs

Site Activation

Feasibility Studies

SOP Compliance

Data Analysis

Clinical Systems

Questionnaire Creation

Stakeholder Communication

Project Management

Bilingual French English

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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