Copenhagen, DNK
8 hours ago
Associate Start Up & Regulatory Manager
**Associate Regulatory & Start‑Up Manager** **Clinical Operations | Regulatory & Site Activation** **Location:** Flexible / office‑based depending on project needs **Travel:** Occasional travel may be required **Contract Length:** 4-6 months Are you looking to take the next step in your Regulatory & Start‑Up career within clinical research? We are seeking an **Associate Regulatory & Start‑Up Manager** to support and deliver site activation, regulatory, and maintenance activities across clinical studies, working closely with cross‑functional teams and global stakeholders. This role offers the opportunity to build leadership capability, contribute to complex international studies, and play a critical role in bringing new therapies to patients. **The Role** As an Associate Regulatory & Start‑Up Manager, you will support the delivery of **site activation and maintenance activities** for assigned studies or multi‑protocol programmes. You will help ensure regulatory submissions, contracts, and essential documents are managed compliantly and efficiently, while developing your leadership and project management experience. You will work as part of the study management team, contributing regulatory expertise throughout study start‑up and maintenance phases. **Key Responsibilities** + Support the execution of **site activation and maintenance activities** , including pre‑award and bid defence activities + Assist in developing and maintaining **Regulatory & Start‑Up Management Plans** aligned to project scope and timelines + Contribute to defining **regulatory strategy** , submission pathways, and authorisation requirements + Prepare, review, and track **regulatory and contractual documentation** , ensuring timely execution + Identify regulatory challenges and support the development of **practical solutions** + Monitor site performance metrics and support compliance with SOPs, GCP, ICH, and applicable regulations + Collaborate with regional, country, and global teams to deliver study milestones + Maintain accurate records within **CTMS** , databases, timelines, and tracking tools + Support Quality Management activities to ensure appropriate standards are maintained + Provide input into client communications, presentations, or training where required + Support budget planning and study tracking activities as needed + Actively develop leadership skills, including mentoring or supporting junior colleagues **About You** You are a motivated regulatory professional with a solid foundation in clinical research and a desire to grow your responsibilities and impact. **You will bring:** + A **Bachelor’s degree** in a related scientific or clinical field + Typically **2–3 years’ relevant experience** in clinical research + Around **3 years’ clinical research experience** , including exposure to leadership or coordination responsibilities + Good knowledge of **clinical research processes, medical terminology, and regulations** + Experience working with clinical systems and strong **Microsoft Office** skills + Strong communication, organisational, and interpersonal skills + The ability to manage multiple tasks and priorities with attention to detail + Confidence working both **independently and collaboratively** + A proactive, solution‑focused mindset with the ability to build strong working relationships **What We Offer** This is an excellent opportunity for someone looking to **step into greater responsibility within Regulatory & Start‑Up** , gain exposure to global studies, and develop leadership capability within a supportive and collaborative clinical research environment. \#LI-HCPN \#LI-CES \#LI-DNP \#LI-CT1 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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