Senior Clinical Data Lead (CDL)

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

• As Senior Clinical Data Lead within our Clinical Data Management (CDM) division, 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 critical thinking, collaboration and communication skills, and an entrepreneurial mentality.
• 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,

Senior Clinical Data Lead (CDL) 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.