Senior Clinical Data Manager

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $93k - $120.8k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Provide subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials • Support activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead • Design and test CRFs, edit checks, reports, and listings • Create documents, clean data, manage queries, and identify and mitigate risks • Act as backup to the Clinical Data Lead and support cross-functional teams • Apply data strategy and confirm use of global standards • Assist in monitoring and reporting overall study progress • Review study data comprehensively according to Biogen processes, regulatory guidelines, and study-specific plans • Reconcile data collected in EDC with safety databases and external vendor systems • Investigate issues and recommend solutions • Review study metrics, communicate data topics across internal and external teams, and escalate issues for timely resolution • Contribute to Data Management process creation, improvement, and innovation • Support assessment of vendor quality and efficiency • Participate in cross-functional collaborations, study-level activities, and special projects

🎯 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, preferably Medidata Rave • Experience using data review tools, preferably Elluminate • 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 • Subject matter expertise among Clinical Data Management peers

🏖️ Benefits

• Short-term and long-term incentives, including cash bonus and equity incentive opportunities • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation • Additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays • 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation • Opportunities for learning, growth, and expanding skills