Senior Director, rCDI (Rare Disease Clinical Data & Insights)
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.
This is what you will do:
The Senior Director, rCDI (Rare Disease Clinical Data & Insights) has experience managing staff and projects in several programs to deliver portfolio-wide data management services from a core team of clinical data management experts and risk-based quality management. This individual must have experience in a highly regulated environment and be prepared to present data and documentation supporting regulatory requirements for complete and accurate data. This individual may have several therapeutic areas and specialty services within their accountabilities.
You will be responsible for:
The performance and productivity of several therapeutic areas/specialty services in rCDI operations while supporting or leading senior leadership initiatives to increase rCDI productivity and create and govern models for the following: rapid study start and database cuts/locks, cross-functional and vendor governance, oversight, and operational enhancements, models for efficiencies and relationship building for phase-centric modeling, and models for risk-management.
Leading direct-line and vendor-associated performance management measured by quality outputs tracked by key performance indicators while ensuring staff uses good clinical practice, risk-based processes, pro-active management of data quality oversight, and strategy for budget and resourcing.
Sponsoring process improvements within data management and across functions, including process and system enhancements and adoption roll-out by authoring, reviewing, publishing, and reviewing policies and methods in standard operating procedures, work instructions, job aids, and other training documents, and ensuring that technology enhancement goals are met (e.g., implementation and roll-out of elluminate).
Developing transparent accounting and reporting expectations based on contract and operational guidelines for all business relationships, including providers of tasks and technology, from requests for proposals to service completion, and seeking prospective partnerships for improved depth and breadth of DM service.
Developing a team of highly productive professionals and leaders who excel in data management operations and demonstrate a next-generation aptitude.
Coaching, mentoring, supporting career development, performance management, and succession planning of the team.
Facilitating internal information sharing amongst departments to promote learning and best practices.
Hiring, developing and retaining talent.
Influencing the vision and strategy of the rCDI function, focusing on using advanced technologies, promoting risk-based data-driven decision-making, fostering collaboration among cross-functional teams, emphasizing the importance of quality data, and advocating for continuous improvement in processes.
Staying informed on industry trends, regulatory requirements, and emergent data collection, data management, visualization and provision tools and applications to align the CDM strategy with evolving standards.
You will need to have:
Experience in clinical data management of 12+ years with 8 to 10 years managing reports.
A bachelor's degree in a scientific discipline or equivalent (computer science, mathematics, statistics, epidemiology, biology, psychology).
Knowledge of the clinical data management and clinical development process, including regulatory submissions for various agencies (e.g., FDA, MHRA, PMDA), CDASH, application of FAIR (Findable, Accessible, Interoperable, Reusable) principles, MedDRA/WHO-DD dictionary coding and versioning, risk-based processes, digital technology, and data visualization technology.
Exceptional knowledge and experience in clinical data operations and processes with skills supporting immediate step-in capability to start, maintain, and close-out studies, if needed.
High proficiency with technology associated with current and evolving data management practices, including electronic data capture, data aggregating, data visualization and analytics, automated data bots, machine learning/artificial intelligence-based process enhancements, etc.
High-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.
Highly effective written and verbal communication skills are necessary to interact with personnel at all levels within and outside the company.
Experience leading inspection readiness and supporting multiple, global regulatory inspections.
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.
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 in contributing to industry wide initiatives, such as TransCelerate.
Experience in leading the collection of clinical trial and/or Real-World Data.
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.