Regulatory and Start Up Manager, IQVIA MedTech, Poland

Warsaw - Poland

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Overview

Direct and manage the delivery of all required site activation maintenance and regulatory activities for selected studies or multi-protocol programs including pre-award activities oversight of the scope of work budget and resources.

Essential Functions

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy adhering to project timelines.
Develop implement and maintain the Management Plan according to the Scope of Work and Project Plan within the agreed project strategy resolving project related issues where required.
Ensure collaboration across Regulatory & Site Activation including communication with regions and countries to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development initiation and maintenance of clinical trials whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
Assess and review the regulatory landscape and contribute to the collection interpretation analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company as required.
Execute operational strategy/ expectations for maintenance of clinical study approvals authorizations and review/ negotiation of contracts and essential documents.
Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance as applicable).
Mentor and coach colleagues as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS) databases tracking tools timelines and project plans with project specific information.
May take a lead role in developing long standing relationships with preferred IQVIA customers.
Deliver presentations/training to clients colleagues and professional bodies as required.
May be involved in activities related to monthly study budget planning and reviews.

Qualifications and Skills

Bachelors Degree Life sciences or related field
7 years relevant experience in a scientific or clinical environment including demonstrable experience in a global role
Polish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and/or technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Good leadership skills with ability to motivate coach and mentor
Good organizational and planning skills
Ability to exercise independent judgment taking calculated risks when making decisions
Good presentation skills
Proven ability to establish and maintain effective working relationships with co-workers managers and sponsors.
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities

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:

Manager

Job OverviewDirect and manage the delivery of all required site activation maintenance and regulatory activities for selected studies or multi-protocol programs including pre-award activities oversight of the scope of work budget and resources.Essential FunctionsOversee the execution of Site Activat...

Job Overview

Essential Functions

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy adhering to project timelines.
Develop implement and maintain the Management Plan according to the Scope of Work and Project Plan within the agreed project strategy resolving project related issues where required.
Ensure collaboration across Regulatory & Site Activation including communication with regions and countries to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development initiation and maintenance of clinical trials whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
Assess and review the regulatory landscape and contribute to the collection interpretation analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company as required.
Execute operational strategy/ expectations for maintenance of clinical study approvals authorizations and review/ negotiation of contracts and essential documents.
Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance as applicable).
Mentor and coach colleagues as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS) databases tracking tools timelines and project plans with project specific information.
May take a lead role in developing long standing relationships with preferred IQVIA customers.
Deliver presentations/training to clients colleagues and professional bodies as required.
May be involved in activities related to monthly study budget planning and reviews.

Qualifications and Skills

Bachelors Degree Life sciences or related field
7 years relevant experience in a scientific or clinical environment including demonstrable experience in a global role
Polish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and/or technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Good leadership skills with ability to motivate coach and mentor
Good organizational and planning skills
Ability to exercise independent judgment taking calculated risks when making decisions
Good presentation skills
Proven ability to establish and maintain effective working relationships with co-workers managers and sponsors.
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities

Required Experience:

Manager

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

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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

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