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 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.

Introduction to role

Provide expertise for CDM programs, ensuring timely delivery of quality data and fostering positive relationships with collaborators. You'll be tasked with the oversight of leading and successfully delivering complex studies or projects, while also engaging with external partners. Your role involves overseeing Lead Data Managers completing various tasks to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions of studies within a program. Additionally, your involvement in shaping technical landscapes, business strategies, and healthcare environments through contributions to various initiatives is integral. Your proactive approach to sharing insights and experiences with colleagues, both within and outside the department, is crucial. Collaboration with peers across the data management function and throughout the organization to ensure consistent data management solutions are implemented across a program. Timely completion of data management tasks and providing technical expertise while overseeing the project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors are also part of your responsibilities. Critical thinking, teamwork, communication, and innovation are essential for improving data collection and delivering medicines.

Accountabilities:Ultimately accountable for the timely CDM (rCDI) delivery of fit-for-purpose quality data, serving as the primary CDM point of contact at a program level for key partners.Plans, project manages, and oversees CDM-related activities for a program, including resource requirements, risk identification, risk mitigation, prioritization, and timely issue resolution for one or more complex programs.Partners with Directors, rCDI to facilitate mentoring and coaching for CDM staff.Collaborates and influences effectively in a consultative manner with internal and external partners, modeling and encouraging teamwork and collaboration, including addressing blocking issues.Ensures alignment of the CDM program to the development teams' goals and vice versa to positively impact the study quality and outcome.Provides input into the program strategy as a member of or collaborating with senior-level delivery teams as appropriate (e.g., Global Project Team (GPT)).Develops communication strategies to keep collaborators, customers, and team members well informed and updated on strategy, plans, performance, etc.Contributes technical, therapeutic, and business expertise within and external to CDM, including but not limited to current and new technologies and data flow, CDM industry landscape, data standards, therapeutic area expertise, outsourcing expertise, established methodologies, and process improvements.

Essential Skills/Experience:Bachelor’s degree in a scientific field or equivalent experience.Experience in clinical data management of 8-10+ years or with recent and relevant experience managing projects, including deliverables, overseeing inspections, budgets, and resources.Expert knowledge of the clinical data management and clinical development process, including the regulatory submission process for the regulatory agencies (FDA, EU, etc.) and knowledge of CDASH, MedDRA/WHO-DD dictionary coding and versioning, digital technology, and data visualization technology.Highly effective written and verbal communication skills are necessary to interact with personnel at all levels within and outside the company.Strong organizational skills demonstrating the ability to work on multiple complex projects simultaneously while independently managing responsibilities with effective time management and impactful outcomes.Strong ability to solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating pro-active drive, sound decision-making, and attention to detail.High proficiency with technology associated with current and evolving data management practices, including electronic data capture and data aggregating, with exposure to data visualization and analytics, automated data bots, machine learning/artificial intelligence-based process enhancements, etc.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation 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:A master's degree or equivalent experience" in a field related to science.Certification as a Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management.Experience with clinical trial and/or Real-World Data.Good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise.Extensive technical/industry experience.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.