Executive Director overseeing strategic business transformation and execution of global business operations for GDMS. Leading diverse initiatives and coordinating with senior leadership to enhance organizational efficiency.
Responsibilities
Oversees strategic business transformation efforts and coordinates the execution of cross-functional global business operations processes
Enables the effective management of the Global Data Management & Standards (GDMS) organization in alignment with GDMS and broader organizational goals
Sets the vision for the organization and establishes the global business operations framework
Coordinates delivery of services including headcount management; resource forecasting and algorithm management; budget and expense management; financial forecasting; operations reviews; strategic project coordination; change management; communications; and professional development
Leads topic curation and orchestration of senior leadership team meetings and other GDMS forums including global townhalls and Data Management Center (DMC) site visits
Serves as a cross-functional integrator, ensuring tracking and status reporting for GDMS objectives to drive alignment, risk management, and execution against strategic priorities
Maintains and facilitates the reporting of GDMS Key Performance Indicators (KPI) and Key Quality Indicators (KQI) as part of formal operations reviews
Develops strategies to enhance organizational value and efficiency
Leads talent development and performance management activities for Business Operations with a focus on building a high-performing team and fostering a culture of growth and development
Proactively engages with stakeholders to identify opportunities for innovation and continuous improvement
Sponsors and/or leads organizational initiatives Enterprise Leadership Skills – behaviors and impact expected in this role include: Strategic Planning, Execution Excellence, Change Catalyst, Networking & Partnerships
Requirements
Bachelor’s degree in life sciences, operations management, business analytics, or a related discipline
Master’s degree in business, operations management, business analytics or a related discipline
Advanced training or certification in clinical research and/or data management relevant disciplines including, but not limited to: Association of Clinical Research Professional (ACRP) certification; SCDM Clinical Data Manager (CCDM) certification; Lean Six Sigma; or Project Management Professional (PMP) certification
15+ years in clinical data management and operations within the pharmaceutical or biotech industry with Bachelor’s degree, or 13+ years with Master’s degree
10+ years in progressive leadership roles managing operations in clinical data management or clinical operations functions, including resourcing and budget management
10+ years of experience and demonstrated success in personnel management, including direct line management of managers and functional leaders in a matrixed, global organization
7+ years proven track record directly managing stakeholder partnerships to enable successful operations delivery and support (ex. FSPs, technology, support services)
Demonstrated experience designing and implementing cross-functional, global operational processes and frameworks
Knowledge of full CDM lifecycle: data collection and validation design, data capture, data cleaning and reconciliation, database lock, and study close out
Familiarity with applicable regulations (ICH E6 R3, 21 CFR Part 11)
Strong analytical, problem-solving, and negotiation abilities with a pragmatic approach to balancing timelines, quality, and cost
Ability to convert complex technical concepts into clear, concise, and actionable communications for nontechnical executives and cross-functional stakeholders.
Outstanding written and verbal communication skills that can be deployed across all levels of the organization.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
Senior Manager overseeing GTM business process improvements at Equinix. Collaborating with leadership to drive scalable operational models and cross - functional transformations.
Business Process Specialist Apprentice responsible for assisting with technical support and documenting business processes at Liberty University. Streamlining processes and improving departmental efficiencies through technical means.
Senior Technology Business Systems Consultant leading business analysis activities and collaborating on technology solutions. Responsible for evaluating complex business challenges and providing scalable technology solutions.
Manager in Business Operations & Strategy supporting implementation & delivery of systems for Corporate and Institutional Banking. Investigating queries and providing SME input for process improvements.
Business Operations Director at HP, driving operational excellence and partnership strategy with Canon. Leading a team to improve efficiency and reduce costs in Office Printing Solutions.
Business Systems Consultant specializing in Guidewire at Zurich Canada. Analyzing business requirements and translating them into effective solutions within the Guidewire platform.
Head of Supply Chain managing Supply Chain & Business Process for Advanced Industrial Intermediates at LANXESS. Leading staff, optimizing SAP processes, and tracking KPIs in Pittsburgh.
US Medical Affairs Business Operations Lead providing strategic and operational support for the MEI organization. Leading budget management, project implementation, and team coordination across various platforms.
GTM Business Process Architect Manager at Equinix focusing on process improvements and operational efficiency. Collaborating with Sales and Commercial leadership to drive impactful initiatives.
Lead systems implementation and process change within Business Operations and Strategy team at Lloyds Banking Group. Collaborate with vendors and support incident management for robust platform operations.