Senior Manager, Data Management

Location: Boston, MA

Department: Clinical

• Responsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to scope of work and service agreements
• Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners
• Responsible for CRO adherence to project timelines, from study startup through study closeout, ensuring high quality and integrity of all deliverables  
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
• Review data via listings and visualization tools to report on performance and quality; review will be performed with clinical data within studies and across multiple studies for trend analysis
• Contribute to the development, review and implementation of Clinical Data Management processes, policies and SOPs
• Participate in vendor qualifications and audits
• Oversee the planning, execution, and maintenance of major projects and initiatives, if required.
• Lead data management study inspection readiness activities and the support of submission activities as needed.
• Train and mentor DM staff or members of the clinical trial team on processes, projects, systems, and programs.
• Perform hands-on data management responsibilities, if required.

• Bachelor’s degree in a science-related discipline, or equivalent work experience
• 6+ years working in clinical data management at a Sponsor organization with experience across multiple indications and EDC platforms
• Experience developing initiatives designed to promote efficiency and productivity for data management operations
• Extensive knowledge of clinical data management outsourcing models including functional-service providers and full-service CROs
• Experience leading a team of CRO data managers to ensure the timely provision of DM deliverables
• Advanced hands-on knowledge of data management processes and EDC systems
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)
• Experience with data visualization, analytics and reporting tools such as elluminate or SpotFire
• Strong project management skills, and ability to effectively lead and collaborate with various business functions
• Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects
• Experience in solving extremely complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data
• Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously
• Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
• Self-motivated, reliable team member
• CDASH experience
• Demonstrated ability to influence without authority
• Demonstrate initiative, sound judgment and flexibility
• Solid understanding of clinical drug development processes

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission