Hybrid Director, Data Management

at Aura Biosciences

• Job title: Director, Data Management
• Job type: Full Time
• Experience level: Lead
• Salary: $185,000 - $245,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Brighton, United States

About the role

• Director of Data Management at Aura Biosciences leading clinical data management initiatives for drug development. Providing strategic leadership to drive data collection and quality across multiple projects.

Responsibilities

• Provide clinical data management leadership to align on and drive data collection requirements to set a high-performance and collaborative culture.
• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
• Responsible for end-to-end clinical data management activities providing data management representation and leadership on internal cross-functional teams, in addition to regulatory agencies.
• Provide strong quality and project oversight over third party vendor data responsible for data management deliverables.
• Ensure quality processes for data management through subject matter ownership of SOPs, training, and internal and external inspection activities.
• Establish best-in-class processes and standards for the generation and reporting of data.
• Work collaboratively with internal and external team members to coordinate the planning and execution of day-to-day data management deliverables.
• Provide expertise and guidance to the Clinical Development team regarding CDASH and CDISC data standards.
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
• Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines.
• Contribute to project resource planning, re-forecasting, and program milestones.
• Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality.
• Holds accountability to resolve complex issues and proactively develop solutions, within the function and across functions.
• Leveraging technical/functional expertise to develop solutions.
• Using clear communications and collaborative strategies to drive to resolution.
• Manages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials.

Requirements

• BA/BS degree in Computer Science, or a closely related scientific field required
• Master’s or other advanced degree in related field highly preferred
• 10+ years of clinical/statistical data management within the biotech/pharmaceutical industry
• 3+ years of demonstrated leadership experience and career progression
• Experience in the development and implementation of Clinical data management standards and procedures is required
• Creative, capable problem-solver with the necessary attention to details
• Experience leading teams supporting NDA and IND filings
• Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction
• Adept at outsourcing and managing services provided by clinical data management vendors and contractors
• Strong analytical skills and demonstrated experience in gathering, interpreting, and analyzing data in clinical research and drug development
• Extensive experience interacting with regulatory agencies in GCP inspections/audits, both US and ex-US
• Proven strong leadership and project management skills with the ability to influence decisions and achieve results.
• Demonstrated ability in managing internal and external functional/multi-functional teams and/or initiatives
• Excellent interpersonal and communication skills, both verbal and written
• Flexible to changing priorities, detail-oriented, works well under pressure with an initiative to take on unfamiliar tasks
• Demonstrated ability to evaluate the business impact of decisions, follow through on agreed-upon decisions, and remain flexible when needed
• Excellent analytical, problem-solving, and organization skills with the ability to work on multiple tasks
• Ability to communicate technical information to non-scientists, and willingness to educate the internal team
• Strong team player with excellent collaboration skills.

Benefits

• Health insurance with FULL premium coverage
• 401K with company match
• Employee Stock Purchase Program (ESPP)
• Competitive paid time off (PTO)
• Company-paid short & long-term disability insurance and life insurance