Associate Director - Clinical Trials, Clinical Data Lead

Role Summary

Associate Director - Clinical Trials, Clinical Data Lead. The Clinical Data Lead is accountable for technical leadership in the execution of global clinical data management work, driving prioritization and alignment of study deliverables and realizing improvements in clinical data management activities and processes. The position requires coaching and developing, with an in depth understanding of clinical data management, including data collection, data flow, data quality and integrity. This is a hybrid position with 3 days onsite at the corporate center in Indianapolis, IN.

Responsibilities

• Partner with other clinical leaders to provide proactive strategic, scientific and technical input on clinical data planning and execution that enable efficient delivery of these data
• Contribute to project decisions related to global clinical data execution options
• Ensure strong linkages exist between study build, execution, analytics and archival
• Partner closely with Data and Analytics leadership and other functions to effectively plan, forecast, and manage the end to end global clinical data management, validation, study build, and filing/archiving resources required to deliver all sanctioned projects
• Drive efficiency and improvement in the Data and Analytics organization
• Lead large-scale cross Business Unit/Therapeutic Area projects or programs with high complexity

Qualifications

• Master’s degree with a minimum of 3 years of experience (or bachelor’s degree with 7 or more years of experience) in clinical drug development or a related field, with deep technical expertise in clinical data management and execution of data strategies at the compound and study level
• Advanced degree (e.g. MSc, PhD) in a scientific or health care field
• Proven ability to lead development of creative data solutions to address clinical development challenges
• Previous supervisory experience
• Proven ability to develop diverse organizational talent with next level potential
• Passionate about improving technological solutions using new technologies
• Society of Clinical Data Management certification
• Domestic and international travel may be required

Skills

• Technical leadership in clinical data management
• Data planning and execution for global clinical data management
• Agile project leadership for a technical team
• Capability to integrate multi-functional/external information for data-driven decision making
• Regulatory awareness relevant to US, EU, Japan, and China
• Communication and stakeholder engagement at internal and external venues

Education

• Bachelor’s degree or Master’s degree in a related field (as specified above)

Additional Requirements

• Hybrid work arrangement: 3 days onsite at Indianapolis, IN