Associate Director, Clinical Operations

Clinical Operations Lead, Associate Director

As a ClinOps Lead, you will be responsible for the strategic and operational oversight, management, and delivery of clinical trial or trials in support of clinical development strategy. This role is expected to apply knowledge of current local and global regulatory trends to identify future clinical study requirements and strategies. This independent role reports to Clinical Development Operations Director, based in Europe (Switzerland) and works in alignment with the teams in Switzerland and the Netherlands.

Responsibilities

• Ensures proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and standards to achieve project goals, timelines and quality
• Accountable for study execution and drives key decisions
• Authors, provides input, and/or oversees program and/or study level documents.
• Provides proper oversight of CROs and other third party vendors to ensure quality of delivery, financial accuracy, and adherence to timelines
• Manages financial aspects of clinical studies
• Assists in development and improvement of Clinical Operations processes and procedures
• Mentors junior staff
• Manages direct reports (if required)
• Involved in interviewing, hiring, and training employees
• Involved in vendor selection including critical review of contracts, and/or work orders and management of ongoing performance.
• Collaborates on SOP development
• Proactively identifies, manages, and escalates issues related to clinical programs
• In collaboration with appropriate study team members, identifies study quality issues and assist with creation and implementation of corrective actions and preventative actions (CAPA) as needed

What your profile could look like…

• Bachelor’s degree required. Scientific/health care field preferred. Advanced degree preferred.
• Clinical operations experience (8 years) with evidence of increasing responsibility within a pharmaceutical/biotech company or CRO
• Strong background in project management. Ability to multi-task and manage workload independently
• Experience leading cross-functional teams
• Ability to work strategically within a business-critical and high-profile development program
• Critical thinking and a good understanding of the scientific and clinical components of studies in therapeutic area.
• Excellent verbal and written communication and presentation skills (English)
• Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results
• Excited and driven by science and the vision to improve disease management and patient care