Sr Clinical Data Manager, WCH
Biogen
Summary
The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. You will be responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead.
Job description
About This Role
The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. You will be responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead.
What You’ll Do
- Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation.
- Act as the back up to the Clinical Data Lead, providing subject matter expertise and support to cross functional teams.
- Applies data strategy, confirms use of global standards, supports cross functional study team members, and assists in monitoring and reporting overall study progress.
- Accountable for comprehensive review of study data, ensuring all tasks are performed according to Biogen processes, regulatory guidelines, and study specific plans.
- Performs or oversees the reconciliation of data collected in EDC with other sources, such as the safety database and external vendor systems.
- Investigates issues and recommends solutions using experience, judgement, and precedent.
- Reviews study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution.
- Contributes to the development of Data Management process, including new process creation, process improvement, and innovation.
- Supports the assessment of vendor quality and efficiency, including Data Management FSP team members and external vendor data providers.
- Participates in cross-functional collaborations, including study level activities and special projects or initiatives.
Who You Are
You are recognized as a subject matter expert amongst Clinical Data Management peers. You enjoy supporting project teams, collaborating through thoughtful communication, and sharing and gaining Clinical Data Management knowledge to positively impact studies, programs, and the organization.
Required Skills
- Bachelor’s degree strongly preferred in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc
- 4+ years of Clinical Data Management experience required
- Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools (Elluminate preferred).
- Project management skills to effectively 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.
- Understanding of drug development and the biopharmaceutical industry.
Requirements
- Bachelor’s degree strongly preferred in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc
- 4+ years of Clinical Data Management experience required
- Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools (Elluminate preferred).
- Project management skills to effectively 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.
- Understanding of drug development and the biopharmaceutical industry.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- Paid Vacation
- Paid Holidays
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.