Principal, Clinical Data Lead

Biogen2 Locationsremote$122k–$163kView the original posting at Biogen ↗

Preference will be given to candidates who can work in a hybrid arrangement, with weekly presence onsite at our offices in Cambridge, MA or in Durham, NC. However, remote work may be available for highly qualified candidates residing within the United States. About this role The Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. Manage the flow of clinical data throughout the study lifecycle, from initial eCRF development through clinical study reporting. This role serves as the accountable Data Management representative on study teams, ensuring high-quality data deliverables, effective planning, risk management, vendor oversight, inspection readiness, and successful study execution. The position may support program-level responsibilities, special initiatives, quality oversight, process improvement, and mentoring of Clinical Data Managers. What you'll do Lead end-to-end clinical data management activities across assigned studies and programs. Serve as the single point of contact for execution of data management deliverables on assigned studies and programs. Ensure consistent application of DM standards and quality across assigned trials. Develop and oversee risk mitigation and action plans. Monitor study metrics, identify trends, and escalate risks as appropriate. Partner with internal and external stakeholders including Biometrics, Clinical, Medical, Safety, Regulatory, CROs, and FSP partners. Perform holistic review of study data using data review and analytics tools. Drive process improvement, innovation, and operational excellence initiatives. Manage vendor performance and quality issues and support audit and inspection readiness. Support special projects and cross-functional initiatives. Who you are A passionate and experienced clinical data leader with exceptional planning, communication, and leadership skills. You bring deep expertise in clinical data management systems, maintain a strong focus on quality and detail, and take accountability for the successful delivery of all CDM outputs. Required skills Bachelor's degree in a scientific or quantitative discipline preferred. 5-7 years of clinical data management experience with accountability across study start-up, conduct, and database lock. Robust experience with EDC platforms such as Medidata Rave and data review tools including eCS elluminate. Deep understanding of drug development and the biopharmaceutical industry. Strong project management skills with the ability to lead cross-functional teams; project management certification preferred. Exceptional attention to detail and ability to manage multiple competing priorities. Experience building and maintaining effective external stakeholder and vendor relationships. Deep knowledge of data management outsourcing models, including FSP and CRO partnerships. Demonstrated ability to influence without formal authority. Excellent written and verbal communication skills. Preferred skills Project Management certification. Base salary varies depending on location. Job Level: Management Additional Information The base compensation range for this role is: $122,000.00-$163,250.00 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 includi

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