Poland Job Openings
IQVIA
Regulatory and Start Up Specialist 2 - Poland
FULL TIME
October 16, 2024
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.\
Fluent in both Polish and English - Hybrid
Essential Functions
Qualifications
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
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
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.\
Fluent in both Polish and English - Hybrid
Essential Functions
- 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.
Qualifications
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- 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 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.
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
We regret to inform you that this job opportunity is no longer available as it has expired
New Job Alerts
KPMG Poland
Executive Consultant - Financial Services - Actuarial Advisory
November 15, 2024
View Job Description
Toyota Motor Manufacturing Poland
Specjalista / Starszy Specjalista (m/k) w obszarze Biznes Partneringu
Wałbrzych
November 15, 2024
View Job Description
KPMG Poland
Consultant / Junior Consultant - Financial Services - Credit Risk
November 15, 2024
View Job Description
Looking for similar job?
Amazon Fulfillment Poland sp. z o.o. - D15
Graduate Area Manager - Summer 2025 Start - Poznan Area
Poznań
FULL TIME
October 4, 2024
View Job Description
Amazon Fulfillment Poland sp. z o.o.
Graduate Area Manager - Summer 2025 Start - Łódź Area
Pabianice
FULL TIME
October 4, 2024
View Job Description
Novartis
Study Start-up Clinical Research Associate -Poland ( Home based)
FULL TIME
September 20, 2024
View Job DescriptionNew Job Alerts
KPMG Poland
Executive Consultant - Financial Services - Actuarial Advisory
November 15, 2024
View Job Description
Toyota Motor Manufacturing Poland
Specjalista / Starszy Specjalista (m/k) w obszarze Biznes Partneringu
Wałbrzych
November 15, 2024
View Job Description
KPMG Poland
Consultant / Junior Consultant - Financial Services - Credit Risk
November 15, 2024
View Job Description