Copenhagen, DNK
2 days ago
CSA Specialist
**Site Activation Specialist** **Location:** Denmark **Work Model:** Hybrid **Job Overview** Under moderate supervision, the Site Activation Specialist is responsible for executing feasibility, site identification, regulatory, site start‑up, and maintenance activities at the regional or country level. This role ensures compliance with applicable regulations, SOPs, and project requirements. The Site Activation Specialist prepares and manages site documentation; reviews, negotiates, and tracks regulatory and site-related documents; maintains site performance metrics; and serves as the primary point of contact for investigative sites. The role also supports the establishment of project timelines and ensures that contracts and essential documents are fully executed in line with budgetary and contractual guidelines. **Essential Functions** + Serve as a **Single Point of Contact (SPOC)** for assigned studies, performing feasibility, site activation, and selected maintenance activities for investigative sites under moderate oversight. + Work closely with the **Site Activation Manager (SAM)** , Project Management, and cross‑functional teams to support site start‑up and ongoing site activities. + Prepare and review site documents for completeness, accuracy, and consistency, with guidance from senior staff. + Review, track, and follow up on the collection, approval, and execution of key documents, including: + Feasibility questionnaires + Confidential Disclosure Agreements (CDAs) + Regulatory and ethics submissions + Informed Consent Forms (ICFs) + Investigator Pack (IP) release documentation + Communicate status updates and completion of regulatory, contractual, and other site-level documentation to project team members. + Distribute approved and completed documents to investigative sites and internal stakeholders. + Update and maintain internal systems, databases, trackers, timelines, and project plans with accurate and timely study information. + Support site performance tracking and ensure adherence to applicable local and international regulations, SOPs, and work instructions. **Qualifications** + **Bachelor’s degree** in Life Sciences or a related field (required). + **1–3 years of experience** in clinical research or a relevant healthcare-related role, or an equivalent combination of education, training, and experience (required). + **Up to 3 years of experience** in a healthcare or clinical research environment, or equivalent experience (preferred). + Strong understanding of clinical trial processes, regulatory requirements, and GCP principles. + Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities. + **Native or fluent Danish** (required). + **Fluent English** , both written and spoken (required). 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 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
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