Clinical Study Manager | Clinical Operations
Manage, lead and motivate cross-functional project team, facilitating the team’s ability to fulfill their responsibilities in accordance with project contracts, contract amendments, applicable regulatory, GCP and SOP requirements and company policies and procedures. Function as primary liaison between client, third party vendors and Exom Group clinical operations manager for project issues, including initiating planning, executing, monitoring and controlling and closing out of assigned studies.
Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects.
Manage day-to-day operational aspects of assigned projects including third party vendor activities.
Develop and maintain close working relationship with the client’s study management team(s) to ensure client satisfaction, operational and customer service excellence.
Lead internal and client project team meetings (e.g. Kick-off meetings, teleconferences) and participate and present in investigator or project team trainings as required.
Proactively manage project budget, including scope and scope changes, budget versus actual costs, forecasting and margin evaluations.
Oversee the financial activities of the project by recognizing the appropriate revenue and working with the Finance Department to ensure project invoices are accurate and timely.
Working with the Exom Group functional department managers, determine and manage project resource needs and utilization according to project contract and contract amendments.
Communicate to appropriate Exom Group management, client and third party vendors as warranted on project progress, potential risks and appropriate recommendations for identified risks.
Ensure project documentation is complete, current, stored appropriately and audit-ready.
Participate in business development activities as required.
Perform other duties as assigned by management.
- A minimum of a Bachelor’s Degree in a Life Science.
- Extensive experience of working in a pharmaceutical or CRO environment.
- Previous project management experience in an international environment, with various therapeutic areas.
- Fluency in both English and Italian.
- An understanding of budget and proposal management.
- Proven knowledge and experience working in a FDA/EMA regulated GxP environment, in a biotechnology/pharmaceutical/CRO environment.
- Ability to manage complexity and manage a diverse team – strongly influencing, negotiating, and leading at different levels in a metrics organization.
- Excellent management skills, written and oral communication and interpersonal relationship skills, organizational/prioritization skills, and multi-tasking.
- Ideally, experience in the use e-TMF, CTMS and RBM
- Ensures compliance and consistency of clinical trial CTMS systems.
- Language: English (excellent)