Role Summary
Digital Clinical Operations Vendor Category Lead Overview- This role requires a unique blend of clinical operations knowledge, digital transformation expertise, and vendor portfolio management to drive innovation while ensuring operational excellence. The Clinical Operations Vendor Category Lead (COVCL) is fully accountable for the end-to-end operational strategy and delivery of their assigned service line / vendors performance to drive operational excellence measured in acceleration of study activities, study optimization, and enhanced quality. Create a working environment that encourages high vendor operational performance and innovation.
Responsibilities
- Oversee the end-to-end digital vendor landscape for clinical trials, including: Core R&D digital platforms and systems. Emerging technology vendors AI/Machine Learning solution providers Digital biomarker understanding to coordinate with the strategy team Clinical trial innovation partners
- Collaborate with Digital R&D (dotted line) to align vendor strategies with broader digital transformation initiatives
- Drive MVP (Minimum Viable Product) evaluations and make data-driven decisions on vendor progression or termination
- Identify opportunities for vendor consolidation and core partner strategy (new capabilities) to support key assets
- Thoughtful Risk Taking on vendor capabilities
Qualifications
- Bachelors degree in relevant field (Health Sciences, Clinical Research, or related discipline)
- Minimum 8 years experience in Digital Clinical Operations and or Clinical Operations Vendor Management
- Experience of working with an internal team & Strong Business Acumen
- Significant proven experience in vendor management, vendor oversight, and clinical operations knowledge and managing clinical studies with strong project management skills
- Results Oriented- someone that focuses on the outcomes and demonstrates the ability to think differently and prioritizes outcomes / achieving the goals defined. Driven to deliver business impact
- Solid knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA and EMA, and SOPs/ QDs
- Strong in leadership, decision making, thoughtful risking taking and problem-solving skills. Strong critical thinking skills; able to identify and anticipate study risks
- Agile and able to deal with frequent changes, delays or unexpected events in clinical studies. Strong ability to Act for Change
- Strong Interpersonal and Analytic Skills. Excellent written and verbal communication skills. Strong influencing skills to effectively build relationships with internal and external stakeholders. English language skill: ability to exchange fluently, lead international meetings, analytics ability to dive into data driving operational delivery, write meeting minutes/ emails/ study documents, internal & external communications
Skills
- Vendor governance and oversight
- Operational strategy and performance management
- Change management and process improvement
- Stakeholder management and cross-functional collaboration
- Data-driven decision making and KPI/QPIs tracking
- Regulatory knowledge (FDA, EMA, GCP/ICH)
Education
- Bachelorβs degree in Health Sciences, Clinical Research, or related discipline