Biogen seeks a highly motivated and experienced Senior Clinical Data Manager to join their dynamic team. This role is crucial for ensuring the quality, accuracy, and timely delivery of clinical data across various study phases. The ideal candidate will possess a strong understanding of clinical data management principles, GCP guidelines, and EDC systems, coupled with excellent communication and problem-solving skills.
The Senior Clinical Data Manager will provide support to a Clinical Data Management team, ensuring the delivery of efficient and high-quality clinical data management products. Responsibilities include: contributing to the design, specifications, and development of eCRFs, maintaining adherence to Biogen standards; coordinating the development and testing of edit checks, listings, reports, and tools for data review and discrepancy management.
The role also encompasses developing Data Management Plan documents to guarantee accurate, timely, and consistent clinical data delivery. Furthermore, the Senior Clinical Data Manager will collaborate with Third Party/External Data Vendors to establish data import and reconciliation processes. Comprehensive review of all study-generated data, including Third Party/External, SAE, and local lab data, is essential. Overseeing quality control procedures and fostering strong communication and working relationships within the CDM team are also key responsibilities. The Senior Clinical Data Manager will effectively manage project timelines and quality, providing reports, status updates, feedback, and advice to study stakeholders on data cleaning and risk identification/mitigation activities. This role requires adherence to Good Clinical Practice, ICH Guidelines, Biogen SOPs, Job Aids, regulatory guidelines, and study-specific plans. Applying best practices and independently offering project solutions to the study team is expected. Ensuring activities align with study timelines, quality, and governing processes is crucial. Supporting the filing of eTMF documentation for an inspection-ready environment throughout the study lifecycle, as well as supporting subordinate staff for assigned trials and providing backup support for the Principal Clinical Data Lead when needed, are further responsibilities. The Senior Clinical Data Manager will also be accountable for the timely and comprehensive review of clinical study data listings, ensuring all tasks adhere to Biogen processes, regulatory guidelines, and study-specific plans. Reconciliation of key data points collected in EDC with other sources such as the Safety Database and Third Party/External Data Vendor systems is also required. Effective communication across functions and organizations is essential to ensure issues are resolved according to guidelines and requirements. Supporting the design and testing of technical CDM components, including eCRFs, Edit Checks, reports, and listings, and managing the effective communication of data issues and discrepancies to study sites via the query management process, are critical aspects of this role. The Senior Clinical Data Manager will escalate relevant issues to the clinical study management team for timely resolution. Investigating and analyzing possible solutions using experience, judgment, and precedent is expected, with the ability to propose alternatives and exercise judgment based on experience
Senior Clinical Data Manager Clinical Data Management Ecrf EDC Good Clinical Practice GCP Data Analysis Quality Control Regulatory Compliance Biogen
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Sr Clinical Data Manager - San Francisco, California job with BiogenAbout This Role The Senior Clinical Data Manager will serve in a support-level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products. He/she will also: Support the design, specifications, and development of eCRFs, ensuring adherence to Biogen standards throughout.
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