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Job Overview The Sr. Regulatory & Start Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard o…
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Full-time
bachelor degree
Posted 10d ago
~40 hrs/week
Responsibilities
The role involves managing the strategic, operational, and financial delivery of site activation activities including site selection, regulatory processes, and contracting. The manager will oversee project timelines and ensure compliance with international clinical research standards and internal policies.
Requirements
Candidates must hold a Bachelor's degree in a life science field and possess at least 3 years of relevant experience in a clinical or scientific environment. Strong knowledge of medical terminology, clinical systems, and regulatory requirements is essential for this position.
Full job description
Job Overview.
Direct and manage the execution of the strategic, operational, and financial delivery of required Site Activation activities, including but not limited to Site ID and Selection, Ethics and Regulatory processes and Site Contracting for assigned studies at local level.
Essential Functions:
Provides strategic planning and project oversight accelerating Site Activation through best in class project management to ensure fast site activation for patient enrollment.
Oversee the execution of Start Up (including pre-award through Site Activation) and/or Lifecycle Maintenance for assigned projects in accordance with the agreed start up strategy, adhering to agreed project timelines and in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol, customer requirements, and internal policies.
Develop, implement and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Provide ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues.
Qualifications:
Bachelor's Degree Life Science or related field. At least 3 years relevant experience in a scientific or clinical environment.
Demonstrable experience in an international role; or equivalent combination of education, training and experience.
In-depth knowledge of clinical systems, procedures, and corporate standards Strong knowledge of medical terminology and regulations.
Effective communication, organizational, and interpersonal skills.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US