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)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementoperations managementbusiness analyticsresource forecastingbudget managementfinancial forecastingchange managementperformance managementdata collection and validation designdata cleaning and reconciliation

Soft Skills

strategic planningexecution excellencechange catalystnetworkingpartnershipsanalytical abilitiesproblem-solvingnegotiationcommunication skillsstakeholder engagement

Certifications

Association of Clinical Research Professional (ACRP)SCDM Clinical Data Manager (CCDM)Lean Six SigmaProject Management Professional (PMP)