Job Description

Senior Clinical Data Manager

The Senior Clinical Data Manager will serve in a support-level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products. The role includes supporting the design, specifications, and development of eCRFs, ensuring adherence to Biogen standards throughout. Coordination of the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities is also required. The role involves supporting the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data. Work 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. Oversee quality control procedures. Develop and maintain strong communications and working relationships with CDM team. 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. Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Biogen SOPs, Job Aids, regulatory guidelines, and study specific plans. Apply appropriate best practices and independently offer project solutions to the study team. Ensure activities that are performed are done in line with study timelines, with quality and in compliance with governing process. Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle. Support and assist subordinate staff for assigned trials. Provide back up support for Principal Clinical Data Lead as required.

What You'll Do

• Accountable for on-time and comprehensive review of clinical study data listings, ensuring that all tasks are performed in accordance with Biogen processes, regulatory guidelines, and study specific plans.
• Oversees and/or performs the reconciliation of key data points collected in EDC with other sources such as the Safety Database and Third Party/External Data Vendor systems. Communicates effectively across functions and organizations to ensure that all issues are resolved according to guidelines and requirements.
• Support the design and testing of technical CDM components including eCRFs, Edit Checks, reports, and listings.
• Manages the effective communication of data issues and discrepancies to study sites via the query management process. Escalates relevant issues to clinical study management team to facilitate timely resolution. Investigates and analyzes possible solutions using experience, judgement and precedent, has autonomy to propose alternatives and exercises judgement based on experience.

Required Skills

• Bachelor's degree is 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
• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J-Review or Business Objects is required.
• Deep understanding of drug development and biopharmaceutical industry is required.
• Strong technical skills, including experience working with using Microsoft Excel functionality, is required.
• Ability to work under pressure, demonstrating agility through effective and innovative team leadership is required.
• High attention to detail, including proven ability to manage multiple, competing priorities is required.
• Excellent written and oral communication skills in English is required.

Job Level: Professional

Additional Information

The base compensation range for this role is: - 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: 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

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.

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