Opportunity OverviewThe Senior Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program. The successful candidate will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout. They will be responsible for the oversight and management of clinical data management activities outsourced to CROs. The Senior Manager, Data Management will also contribute to the Rhythm data management operational improvement efforts to identify, develop, and implement departmental standards, applications, processes, and training.
Responsibilities and Duties- Responsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to scope of work and service agreements
- Participate in the development of 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
- Responsible for escalations within Rhythm around risks to data quality or project timelines
- 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.
Qualifications and Skills- Bachelor's degree in a science-related discipline
- 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
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $135,000 - $215,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
