Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

REQUIRED SKILLS

• Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc..
• 7+ years relevant work experience within the pharmaceutical/biotech industry, with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
• Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools, such as J-Review or Business Objects.
• Strong project management skills and ability to effectively lead and collaborate with various business functions.
• Strong written and verbal communication skills and the ability to communicate to a variety of cross-functional teams in a variety of scenarios.
• High attention to detail, including proven ability to manage multiple, competing priorities successfully.
• Deep understanding of drug development and biopharmaceutical industry.
  Job Level: Management

ABOUT THIS ROLE

The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They will provide operational leadership and be accountable for all Clinical Data Management activities throughout the clinical study lifecycle.

WHAT YOU’LL DO

• Single point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress.
• Accountable for all Data Management activities throughout the clinical study lifecycle. This includes oversight of all Data Management tasks and will also include performing tasks such as document creation, data cleaning, and query management.
• Accountable for Data Management standards across assigned trials and programs. Ensures high utilization of CRF and edit check standards library components.
• Develops and executes plans for risk identification and mitigation.
• Reviews operational metrics and trends and initiates process and efficiency optimization.
• Contributes to the development of Data Management process, including new process creation, process improvement, and innovation as applicable.
• Manages quality and efficiency performance with vendors, including Data Management FSP team members and external vendor data providers. Develops and implements strategies and plans for improvement when needed.
• Leads and participates in cross-functional collaborations on study teams and for special projects, providing Data Management expertise and highlighting.
• Supports special projects and initiatives.