Global Study Associate Manager

<p>Are you ready to make a difference in the world of clinical research? As a Global Study Associate Manager (GSAM), you'll be at the heart of delivering clinical studies from inception to completion. This pivotal role within Development Operations involves collaborating with internal and external partners to ensure the seamless execution of clinical studies across various therapeutic areas and phases. Your responsibilities will include supporting global study teams, leading administrative activities, overseeing compliance tracking systems, and providing vendor oversight support. Dive into a dynamic environment where your contributions will directly impact the development of life-changing medicines!</p><p></p><p><u><b>Accountabilities:</b></u><br/>In collaboration with the global study team and key vendors, you'll support clinical study execution, ensuring adherence to timelines and quality standards. <br/>• Lead the preparation of study documents and vendor-related documents, such as the Vendor Oversight Plan.<br/>• Facilitate interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.<br/>• Collaborate closely with partners to execute delegated aspects of the clinical study, aligning with objectives set by the GPD, GSAD, or GSM.<br/>• Contribute to planning and execution of internal and external meetings.<br/>• Identify risks and issues, developing mitigation and action plans.<br/>• Support GSM in project and budget management.<br/>• Participate in or lead departmental initiatives and SME functions.<br/>• Mentor team members, promoting professional development and collaboration.<br/>• Provide support for other study and functional activities as assigned.</p><p></p><p><u><b>Essential Skills/Experience:</b></u><br/>• Bachelor’s degree or equivalent in clinical practice/health care, life sciences, or drug development, or commensurate work experience.<br/>• Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and SharePoint Online, eTMF and Veeva Systems).<br/>• Excellent organizational communication and time management skills.<br/>• Highly proactive and willing to take initiative.<br/>• Strong relationship building skills.<br/>• Ability to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.</p><p></p><p><u><b>Desirable Skills/Experience:</b></u><br/>• Over 3 years supporting global study teams in a clinical research environment.<br/>• Ability to drive discussions around the scope of work and oversee vendor-related activities.<br/>• Excellent knowledge of Essential Documents, CFR, and/or ICH-GCP.<br/>• Demonstrated ability to collaborate as well as work independently.<br/>• Project management skills and basic PM methodology.</p><p></p><p>When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.</p><p></p><p>Joining AstraZeneca means stepping into a world where innovation meets compassion. Our commitment to rare disease biopharma places us at the forefront of biomedical science. With resources and global reach, we push boundaries to translate complex biology into transformative medicines. Our culture is rooted in integrity, inclusiveness, and dedication to making a difference for people living with rare diseases. Here, your career is not just a path but a journey towards impactful change.</p><p>Ready to embark on this exciting journey? Apply now and be part of a team that's redefining healthcare!</p><p></p><p><b>Date Posted</b></p>02-may-2025<p></p><p><b>Closing Date</b></p>22-may-2025<p></p><p></p><p><span>Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, <span><span>sexual orientation,</span></span> age, ancestry, national origin, ethnicity, citizenship status, marital <span><span>status, pregnancy,</span></span> (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic inform