This is what you will do:• As an Associate Director, Portfolio Data Lead, within our Clinical Data Management (CDM) division, you will provide expertise to the leadership of all CDM deliverables across one or more therapeutic area program(s) through all phases, resulting in the successful timely delivery of quality data and strong partnerships with key stakeholders.
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 project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors are also part of your responsibilities.
Your role demands strategic thinking, strong collaboration and communication skills, and an entrepreneurial mindset to innovate data collection methods and ensure the development and delivery of medicines for our patients.You will be responsible for:• 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 handles 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 program(s).• 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 appropriate risk escalation.• 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)).• Builds communication strategies to ensure stakeholders/partners are well informed and kept up to date will all issues 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, best practices and process improvements.You will need to have:• Bachelor's degree in a scientific discipline or equivalent.• 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 handling 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 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 anAccommodation 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.We would prefer for you to have:• A master's degree in a related science field or equivalent.• 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.Date Posted26-Jul-2024Closing Date31-Aug-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
