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Remote, USA, United States of America
Onsite
About This Role
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.
The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle.
What You’ll Do
Primary 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 study lifecycle. This includes oversight of all Data Management tasks and 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.
Assesses operational metrics to optimize process efficiency.
Assesses study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution.
Oversees issue investigation and solution proposals using experience, judgement, and precedent.
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, including study level activities and special projects or initiatives.
Who You Are
You are recognized as an operational specialist in Clinical Data Management and study execution by cross-functional groups. You enjoy leading project teams, collaborating through thoughtful communication, and sharing Clinical Data Management knowledge to positively impact studies, programs, and the organization.
Required Skills
Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
7+ years’ experience in Clinical Data Management within the biopharmaceutical industry.
4+ years’ experience as a Lead 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 (elluminate preferred).
Strong project management skills to effectively lead and collaborate with various business functions.
Excellent written and oral communication skills in English.
Ability to effectively communicate with 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 the biopharmaceutical industry.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.