At AstraZeneca, we're seeking a Global Study Associate to join our clinical study team. As a Global Study Associate, you will support the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management. You will work closely with the Global Study Director, Global Study Associate Director, and/or Global Study Manager to coordinate activities, ensure quality and consistency. Your responsibilities will include initiating and leading the set-up of the electronic Trial Master File (eTMF), maintaining and closing the eTMF to ensure compliance with International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AstraZeneca Standard Operating Procedures (SOPs). You will also provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes.
\nYou will interact and collaborate with internal staff and external stakeholders in the collection of regulatory and other essential documents. You will contribute to electronic applications/submissions in the regulatory information management system by creating and managing clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. You will proactively plan and collate the administrative appendices for the CSR. You will initiate, maintain, and/or support the creation of study documents, ensuring template and version compliance per study-specific requirements.
\nYou will set up, populate, and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools. You will support the set-up, maintenance, and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfill AstraZeneca compliance and meet the regulatory authority needs. You will support the Global Study Director with tracking, reconciliation, and follow-up of the study budget/payments in relevant systems, including the creation and maintenance of purchase orders, running invoice and payment reports.
\nYou will contribute to application, coordination, supply, and tracking of study materials and equipment. You will contribute to the collection of study supplies, if required, at the study close-out. You will coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits, and regulatory inspections, according to company policies and SOPs.
\nYou will lead the coordination and contribute to the preparation of internal and external meetings, such as study team meetings, committee meetings, monitor meetings, Investigator meetings, and virtual meetings. You will liaise with internal and external participants and/or vendors. You will prepare, contribute, and distribute presentation material for meetings, newsletters, and websites.
\nYou will work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with your manager. You will perform other duties as assigned and within the scope of your role.
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\nThis is not a role for someone who primarily keeps calendars tidy,it's for someone who can manage competing priorities, take initiative on complex multi-stakeholder workflows, and represent the company's values with every interaction.
\nYou'll be embedded in a fast-moving, Slack-first culture where things change quickly and attention to detail is the difference between smooth and chaotic. You'll be trusted with sensitive information, high-visibility communications, and a recurring program that touches every employee at KoBold.
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\nCoordinate scheduling, slide preparation, and content review across multiple stakeholders
\nEnsure final presentations are polished, approved, and ready for company-wide all-hands delivery
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\nYou're the kind of person who builds the system before anyone asks you to. You read a process and immediately start thinking about how to track it, who needs a reminder, and what could go wrong at step three.
\nYou communicate with precision,short, clear, no fluff,because you know everyone around you is busy.
\nYou're a natural relationship-builder who earns trust quickly and protects it fiercely.
\nYou treat sensitive information like it was your own.
\nYou bring positive energy to every collaboration and have a natural ability to motivate and enthuse the people around you, even when the work is demanding or the timeline is tight.
\nYou have a sunny disposition that's genuinely yours,you bring good energy because that's just who you are, not because everything is always perfect.
\nYou understand that you're often the messenger in the middle, and you don't take a curt Slack reply personally,you know it's not about you.
\nBased in the Eastern Time Zone
\n7+ years supporting senior executives, ideally two or more simultaneously, in a fast-moving environment
\nExceptional organizational and project management skills,you've owned multi-step workflows with multiple stakeholders before
\nFlawless attention to detail; you're the person who catches the typo in the deck title
\nComfortable in real-time communication tools (Slack preferred) and quick to learn new systems
\nAlready experimenting with AI, or excited to learn
\nProfessional, discreet, and unflappable under pressure
\nAvailable evenings and weekends when the situation calls for it
\nTeam player who will pitch in beyond your immediate scope when needed
\nExperience in a high-growth startup or technology company
\nFamiliarity with coordinating company-wide programs or all-hands events
\nComfort working across time zones with global teams
\nKoBold Metals is an equal opportunity workplace and an affirmative action employer. We are committed to equal employment opportunities for people of any race, color, ancestry, religion, sex, gender identity, sexual orientation, marital status, national origin, age, citizenship, disability, or veteran status.
\nThis position is Full-Time
\nThe US base salary range for this full-time exempt position is $120,000-$140,000, plus equity and benefits including 401k matching.
\nLocation: Remote, but must be East Coast-based
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\nAdditional Information
\nPay & Perks: On-site Opportunity Medical, dental, and vision insurance 401K retirement plan with company match Up to 20 days of PTO per year + company holidays Up to 14 weeks of parental leave (12 for non-birthing parents)
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\nAt Synopsys, we value diversity and inclusion, and consider all applicants for employment without regard to race, color, religion, national origin, gender, sexual orientation, age, military veteran status, or disability.
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