The Global Study Associate Manager (GSAM) is a pivotal role within Development Operations, integral to the global study team. This position supports the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and the development of Clinical Study Reports (CSR) to study archiving. The GSAM collaborates with internal and external partners to manage delegated aspects of clinical studies, including assisting global study teams, leading administrative activities, overseeing compliance tracking systems, and supporting vendor oversight. Studies span various therapeutic areas and all phases (I-IV), including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, and Early Access Programs.
Accountabilities
- Collaborate with the global study team (GPD, GSAD, GSM’s), other ARDU stakeholders, and key vendors to support clinical study execution, ensuring adherence to timelines and quality standards.
- Lead the preparation of study documents and documents related to key vendors, such as the Vendor Oversight Plan.
- Maintain and facilitate interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.
- Work closely with both internal and external partners to execute delegated aspects of the clinical study, ensuring alignment with objectives set by the GPD, GSAD, or GSM.
- Contribute to the planning and execution of both internal and external meetings.
- Identify risks and issues proactively and contribute to the development of mitigation and action plans.
- Support the GSM in project and budget management, adhering to agreed-upon delegation.
- Participate in or lead departmental initiatives and/or Subject Matter Expert (SME) functions.
- Mentor and guide team members, promoting their professional development and fostering a collaborative work environment.
- Provide support for other study and functional activities as assigned.
Essential Skills/Experience
- Bachelor’s degree or equivalent in disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
- Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and SharePoint Online, eTMF and Veeva Systems).
- Excellent organizational communication and time management skills.
- Highly proactive and willing to take initiative.
- Strong relationship-building skills.
- 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.
Desirable Skills/Experience
- Over 3 years supporting global study teams in a clinical research environment.
- Ability to drive discussions around the scope of work and oversee vendor-related activities.
- Excellent knowledge of Essential Documents, CFR, and/or ICH-GCP.
- Demonstrated ability to collaborate as well as work independently.
- Project management skills and basic PM methodology.
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.
At AstraZeneca's Alexion division, we are driven by our commitment to serve patients. Our work is led by their lived experiences, driving what we do and how we do it. We know our patients by name and meet their families. Our focus on their needs allows us to tackle the toughest challenges for them. Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape with a pioneering spirit that makes us unique in R&D and healthcare. Grow and innovate with us in a rapidly expanding portfolio while enjoying an entrepreneurial spirit and autonomy. You’ll be part of an energizing culture where people build connections to explore new ideas and learn. Make an impact by driving change with integrity in a culture that celebrates diversity, innovation, and connection to patients' lived experiences.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.