Study Start-Up Specialist 2, IQVIA Biotech, Poland

Warsaw - Poland

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Study Start-Up Specialist

IQVIA Biotech

Poland Homebased

Job Overview

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.

Essential Functions

As a Study Start-Up Specialist you will work and lead complex projects under general supervision serve as Single Point of Contact in assigned studies for investigative sites Site Activation Manager Project Management team and other departments as necessary.
You will also ensure adherence to standard operating procedures (SOPs) Work Instructions quality of designated deliverables and project timelines.
You will perform feasibility site ID start up and site activation activities according to applicable regulations SOPs and work instructions along with distributing completed documents to sites and internal project team members.
You will also prepare site documents and review for completeness and accuracy along with reviewing tracking and following up the progress the approval and execution of documents questionnaires CDA/SIF regulatory ethics Informed Consent Form and Investigator Pack release documents in line with project timelines.
Coupled with informing team members of completion of feasibility site ID regulatory and contractual documents for individual sites and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.
You may also act as an SME on specific subjects mentor junior CSAs and have a sponsor-facing role.

Qualifications and Skills

Bachelors Degree Bachelors Degree in life sciences or a related field
3 years clinical research experience including 1 year experience in a leadership capacity.
In-depth knowledge of clinical systems procedures and corporate standards.
Good knowledge of submissions for Poland
EUCTR knowledge
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.
Ability to manage multiple projects.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements including local regulations SOPs and companys 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.

Join IQVIA and lets create a healthier world together:

Exposure across 21 Therapeutic Areas
Be part of a global team who operate across 141 locations
Exposure across a variety of studies and projects
Access to new innovative technologies
Work within a collaborative and vibrant environment
Own your career!

Unleash your potential!

It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.

When you join our diverse global team youll harness the power of unparalleled data advanced analytics cutting-edge technologies and deep healthcare and scientific expertise to drive healthcare forward.

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

Required Experience:

Study Start-Up SpecialistIQVIA BiotechPoland HomebasedJob OverviewPerform 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 ...

Study Start-Up Specialist

IQVIA Biotech

Poland Homebased

Job Overview

Essential Functions

As a Study Start-Up Specialist you will work and lead complex projects under general supervision serve as Single Point of Contact in assigned studies for investigative sites Site Activation Manager Project Management team and other departments as necessary.
You will also ensure adherence to standard operating procedures (SOPs) Work Instructions quality of designated deliverables and project timelines.
You will perform feasibility site ID start up and site activation activities according to applicable regulations SOPs and work instructions along with distributing completed documents to sites and internal project team members.
You will also prepare site documents and review for completeness and accuracy along with reviewing tracking and following up the progress the approval and execution of documents questionnaires CDA/SIF regulatory ethics Informed Consent Form and Investigator Pack release documents in line with project timelines.
Coupled with informing team members of completion of feasibility site ID regulatory and contractual documents for individual sites and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.
You may also act as an SME on specific subjects mentor junior CSAs and have a sponsor-facing role.

Qualifications and Skills

Bachelors Degree Bachelors Degree in life sciences or a related field
3 years clinical research experience including 1 year experience in a leadership capacity.
In-depth knowledge of clinical systems procedures and corporate standards.
Good knowledge of submissions for Poland
EUCTR knowledge
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.
Ability to manage multiple projects.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements including local regulations SOPs and companys 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.

Join IQVIA and lets create a healthier world together:

Exposure across 21 Therapeutic Areas
Be part of a global team who operate across 141 locations
Exposure across a variety of studies and projects
Access to new innovative technologies
Work within a collaborative and vibrant environment
Own your career!

Unleash your potential!

It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.

Required Experience:

Key Skills

Sales Experience
Crane
Customer Service
Communication skills
Heavy Equipment Operation
Microsoft Word
Case Management
OSHA
Team Management
Catheterization
Microsoft Outlook Calendar
EHS

Apply Now

About Company

IQVIA

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click