Regulatory & Start Up Specialist I, IQVIA MedTech, Austria at IQVIA

Vienna, Vienna, Austria

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Clinical Research, PharmaceuticalsIndustries

Requirements

B Sc Degree in Life Sciences or related field
1 - 3 years’ clinical research experience
German language proficiency is essential for direct communication with the Competent Authority and Ethics Committees
Good interpersonal communication and organizational skills
Good technology skills and knowledge of MS Office applications
Good attention to detail
General awareness of clinical trial environment and drug development process
Ability to work on multiple projects
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
Ability to work independently, to problem-solve collaboratively and to raise issues appropriately as needed

Responsibilities

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines (may also include maintenance activities)
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions
Distribute completed documents to sites and internal project team members
Prepare site regulatory documents, reviewing for completeness and accuracy
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
Review and provide feedback to management on site performance metrics
Review, establish and agree on project planning and project timelines; ensure monitoring measures are in place and implement contingency plan as needed
Inform team members of completion of regulatory and contractual documents for individual sites
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
Provide local expertise to SAMs and project team during initial and on-going project timeline planning
Perform quality control of documents provided by sites
May have direct contact with sponsors on specific initiatives

Skills

Site Activation

Regulatory Documents

SOPs

Clinical Research

Project Timelines

Quality Control

Tracking Tools

German Language

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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