Hybrid Senior Clinical Data Manager

at Biogen

• Job title: Senior Clinical Data Manager
• Job type: Full Time
• Experience level: Senior
• Salary: $93,000 - $127,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Cambridge, United States

About the role

• Senior Clinical Data Manager at Biogen ensuring adherence to standards in clinical data management processes. Collaborating with teams to deliver accurate and high-quality data for clinical studies.

Responsibilities

• Support the design, specification, and development of eCRFs, ensuring adherence to Biogen standards throughout.
• Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
• Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data.
• Works with Third Party /External data Vendors to complete the set-up of data import and reconciliation processes.
• Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable.
• Oversees quality control procedures.
• With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
• Provide reports, status updates, feedback and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
• Ensures activities that are performed are in with line Biogen’s processes, GCP, Regulatiory Guidelines and Best Practices.
• Provide back up support for Principal Clinical Data Lead as required.

Requirements

• Bachelor’s degree required, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 4+ years of Clinical Data Management experience required
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J-Review, or Business Objects required
• Deep understanding of drug development and biopharmaceutical industry required
• Strong technical skills, including experience working with using Microsoft Excel functionality
• Fluent English (oral and written)
• Strong understanding of drug development and biopharmaceutical industry required
• High attention to detail including proven ability to manage multiple, competing priorities
• Excellent written and oral communication skills

Benefits

• 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 and an 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