Clinical Operation Project Manager

The Senior Regional Project Manager work closely with Sr. Global Study Leader or Global Study Leader to lead and deliver committed components of clinical study to agreed resources, budget and timelines

• Develop and maintain study/essential documents (e.g., Protocol Deviation plan, monitoring plan, etc., including ensuring template and version compliance). Ensures study level performance against agreed upon plans, lead proactive risk and contingency planning and raise issues as appropriate
• Ensure studies are inspection-ready at all times, according to ICH-GCP, Dizal SOP and relevant policies/guidelines
• Provide input towards process improvements.
• Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection
• Work closely with Clinical Training & Compliance team to review audit findings and implement effective corrective action plans.
• As an expert, ensures delivery of a centrally managed study management service across clinical studies from beginning to end. Be the key point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring Dizal oversight of the CRO is defined and performed across relevant Dizal functions for outsourced studies
• Responsible for study budget throughout the study, providing budget progress reports to Global study lead
• Support Global Study Lead and contribute and on overall study delivery. In some situation, play as the acting GSL role to independently manage a study.
• Provides direction to Local study leader/CRA in forecasting study timelines, resources, recruitment, study materials and drugs including resolving any key issues identified.
• Provide input and hold accountability for the development of crucial study level documents (i.e., Clinical study Protocol)
• Ensure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed, taking an active role in the Investigators/Monitoring Meetings
• Monitor study conduct and progress, proactively identify and resolve issues by closely working with global study leader which may impact delivery of the study or to the necessary quality, timeline or budget objectives.
• May be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and to inspire change for new ways to work
• Keeps own knowledge of best practices and new relevant developments up to date.
• Select and lead vendors, handling their performance to ensure high quality, timely delivered services

Education:

University degree (or equivalent), preferably in medical or life sciences or discipline associated with clinical research.

Qualifications:

• Strong communication skills with the ability to build positive relationships, including vendor leadership skills
• Significant experience managing study budgets
• Good understanding of clinical data flow
• Demonstrates ability to prepare and deliver study related training materials
• Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
• Demonstrates ability and willingness to work and lead cross-functionally, e.g., with internal and external partners, on global studies
• Solid understanding of clinical operations and study management processes, along with experience in various phases of development and therapy areas
• Excellent knowledge of spoken and written English
• Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management
• Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical thinking, problem solving, and influencing
• Demonstrated Project Management skills (e.g., leading delivery team)
• Excellent mentoring skills and ability to develop others

Proven ability to prioritize and manage multiple tasks with conflicting deadlines