Sr. Clinical Data Manager

Role Summary

The Senior Clinical Data Manager provides support-level capacity on a Clinical Data Management team to deliver efficient and high-quality clinical data management products. Working closely with the Principal Clinical Data Lead, the Senior CDM ensures that all Data Management activities (from CRF development to Database Lock and eTMF archival) are performed in line with Biogen’s processes.

Responsibilities

• Support the design, specification, and development of eCRFs, ensuring adherence to Biogen standards throughout.
• Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
• Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data.
• Works with Third Party /External data Vendors to complete the set-up of data import and reconciliation processes.
• Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable.
• Oversees quality control procedures.
• With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
• Provide reports, status updates, feedback and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
• Ensures activities that are performed are in with line Biogen’s processes, GCP, Regulatory Guidelines and Best Practices.
• Provide back up support for Principal Clinical Data Lead as required.

Qualifications

• Bachelor’s degree required, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 4+ years of Clinical Data Management experience required
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Robust experience with EDC (e.g. Medidata Rave) and use of Data Review tools such as Elluminate, J-Review, or Business Objects required
• Deep understanding of drug development and biopharmaceutical industry required
• Strong technical skills, including experience with Microsoft Excel functionality
• Fluent English (oral and written)
• High attention to detail including proven ability to manage multiple, competing priorities
• Excellent written and oral communication skills