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 as determined by Company, scope of work and/or sponsor requirements. 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. • Support and/or participate in pre-award/bid defense activities. • 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. • Study Delivery Scope minimum expectations: accountable for 1 region with multiple countries. • 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. • Collaborate with key stakeholders both internal and external, through effective communication and resolution management, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Site Activation Management Plan. • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. • 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. • 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 Management Plan. Requirements • Bachelor's Degree Life sciences or related field Req • At least 8 years with 5 years of lead experience in global scientific or clinical environment.; Req • Demonstrable experience in an international role; or equivalent combination of education, training and experience Req • 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 • In-depth knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines 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 a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled