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Associate Director External Data Strategy

4 months ago

Mississauga, Canada AstraZeneca Full time
About the role:

As an Associate Director, External Data Strategy, within our Rare Disease Clinical Data & Insights (rCDI) division, your responsibilities will revolve around leading, contributing and implementing rCDI strategies. You'll be responsible for leading the development and execution of comprehensive strategies for the acquisition, management, and utilization of external clinical trial data to support drug development and data reuse.

Your proactive approach to sharing insights and experiences with colleagues, both within and outside the department, is crucial. Your role involves leading all aspects of various tasks and implementing process improvements to guarantee the accuracy, completeness, and compliance of data crucial for publications, regulatory submissions and insight creation. Your involvement in shaping technical landscapes, business strategies, and healthcare environments through contributions to various initiatives is integral.

Role & Responsibilites:

Lead the development and be responsible for the implementation of external data strategies that encompass various data types such as digital, eCOA, ECG, Lab, biomarkers, imaging and more.

Establish and manage relationships with internal collaborators, external data providers, technology partners, and research organizations.

Lead multi-functional teams to identify and prioritize external data needs and opportunities for data reuse.

Oversee the integration of external data sources with internal systems and platforms, ensuring data quality, efficiency and compliance with industry standards.

Collaborate with IT, legal, and compliance departments to address data privacy and security issues.

Drive innovation in external data acquisition, data standards and management processes to enhance efficiency and cost-effectiveness.

Monitor and evaluate new technologies and data sources that could provide a competitive advantage.

Develop metrics and KPIs to measure the effectiveness of the external data strategy and make data-driven decisions.

Provide thought leadership and advocacy on the value of data standards, data sharing and reuse, both internally and within the industry.

Prepare and present reports on external data strategy progress and impact to senior management and stakeholders.

Innovating data collection methods and ensuring the development and delivery of medicines for our patients using strategic thinking, strong collaboration and communication skills, and an entrepreneurial mindset.

Proactively identifying gaps and leading functional/cross-functional initiatives to promote new ways of working, including emerging technologies to enable broader and more effective use of data to support the business.

Advising functional peers, key stakeholders, FSPs, CROs, and collaborative groups on technical solutions to ensure high quality external data collection and delivery, and delivering solutions as needed.

Staying informed on industry trends, regulatory requirements, and emergent data collection/acquisition, data management, visualization and provision tools and applications and understanding impact on the CDM strategy and evolving standards.

Coaching and mentoring colleagues.

Requirements:

A bachelor's degree in data science, Computer Science, or related field.

Experience in clinical data management for 6+ years or relevant experience.

Expert knowledge of the clinical data management and clinical development process, including regulatory submission for various agencies (FDA, EU, etc.) and knowledge of CDASH, application of FAIR (Findable, Accessible, Interoperable, Reusable) principles, MedDRA/WHO-DD dictionary coding and versioning, with exposure to 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 proactive drive, sound decision-making, and attention to detail.

High proficiency with technology associated with current and evolving data management practices, including electronic data capture, external non-CRF data, digital data 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:

Experience in external data strategy, management, and analytics, preferably in the pharmaceutical or healthcare industry.

Experience in leading study teams and maintaining oversight of all start-up, conduct and close-out activities for multiple or complex studies, ensuring fit for purpose quality (including oversight of FSPs, Vendors, CROs and Collaborative Groups).

Experience in leading the collection of 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.

Some experience with advanced analytics approaches (e.g., machine learning/AI).

Experience in programming languages (SAS, R, Python, SQL, etc.).

Working Environment:

Hybrid Working Model.

Collaborative team environment with a focus on innovation and continuous improvement.

May require occasional travel.

Date Posted 22-May-2024

Closing Date 20-Jun-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify. #J-18808-Ljbffr