Associate Director Program Data Management Lead

About the Role

Key Responsibilities

• Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM).
• Maintain an overview of clinical program(s) status and issues and proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget; provide CDM program level updates to stakeholders as requested.
• Review plans and provide CDM expertise during protocol design, study start-up and conduct phases of studies. Ensure consistency within the program and development of best practices within CDM. Ensure use of standards for data collection and cleaning.
• Ensure quality deliverables adhere to timelines and are consistent across clinical study deliverables.
• Oversee program level deliverable timelines, ensuring proper resources are in place and monitoring overlapping deliverables.
• Manage CDM study budgets within a program, review initial study budgets, and communicate changes as appropriate.
• Act as point of contact for clinical program and study level escalation.
• Review key metrics and KPIs across studies and within clinical program(s) to track study progress.
• Create and implement risk mitigation strategies proactively.
• Provide innovative and flexible data management solutions and options to cross-functional teams when faced with challenges.
• Lead all aspects of Quality Events, CAPAs, SSN, and process deviations across the program.
• Identify and recommend changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development.
• Attend and represent CDM for a program(s) at review committee meetings as appropriate.
• Participate in CRO governance meetings as needed for clinical program(s).
• Participate in joint meetings with collaborative partners at the study and program level.
• Ensure inspection readiness throughout the clinical program lifecycle and coordinate CDM activities during Regulatory Authority Inspections.
• May be responsible for direct supervision of CDM staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training, and study support/oversight.

Requirements

• Bachelor's degree in Mathematics, Science, or a related field.
• Minimum of 12 years of clinical data management experience in biotechnology, pharmaceutical or health-related industry.
• 5 years of people management experience is preferred.

Qualifications

• Bachelor's degree in Mathematics, Science, or a related field.
• Minimum of 12 years of clinical data management experience.

Benefits & Perks

• Comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.