Senior Clinical Data Lead

This is what you will do:

As Senior Clinical Data Lead you are responsible for independently ensuring the accuracy and timely delivery of clinical data for both study and non-study projects. You will also contribute to the development of new concepts, technologies, and standards. Your role involves performing various tasks to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions.

You will be responsible for:

• Collaborating with peers across the data management function to identify, design, and deliver appropriate data management solutions.
• Completing data management tasks and providing technical expertise while overseeing project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors promptly.
• 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.
• Participating in or leading study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, user acceptance testing, and the development and maintenance of the Data Management Plan and Data Quality Review Plan.
• Participating in or leading data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
• Participating in or leading ongoing operational support for all activities during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock and archiving activities.
• Ensuring that medical coding is completed for all data cuts and reviewed and approved by medical monitors.
• Ensuring that user administration in data management-owned systems and Trial Master File document filing are accurate and timely.

You will need to have:

• A bachelor's degree in a scientific discipline or equivalent.
• Relevant experience in clinical data management for 3 or 4+ years; or equivalent experience at a hospital or research site with knowledge of medical terminology and experience defining, entering, processing, reviewing, and validating clinical data.
• Knowledge of the clinical data management and clinical development process, including the regulatory submissions 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.
• Effective written and verbal communication skills to interact professionally with personnel at all levels within and outside of the company.
• Organizational skills demonstrating the ability to work on multiple projects simultaneously while independently managing responsibilities with effective time management and impactful outcomes.
• Experience in solving highly complex and increasingly difficult problems, taking appropriate corrective action, and identifying and implementing improvements.
• Competence with electronic data management systems, such as Medidata Rave (Rave Safety Gateway, ePRO, eConsent), Oracle Inform, Veeva EDC, etc.; MS Office programs, particularly Word, Excel, and PowerPoint; and data management vendor services.
• 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:

• Knowledge of regulatory requirements for the conduct of clinical data management in global trials.
• Experience in working with study teams and participating in 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).
• Knowledge of CDISC data standards.
• Experience with data analytics and/or visualization tools and techniques.
   

Date Posted

Closing Date

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 accommodations@Alexion.com. Alexion participates in E-Verify.