Senior Local Project Lead (Remote) (Canada) (Clinical)

About the role

As a Senior Local Project Lead you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What Will You Be Doing

Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Senior Local Trial Manager is responsible for the successful management and execution of clinical study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements.

Key Tasks Include (But Not Limited To):

• The efficient management of local vendors
• Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project
• Timely review of trip reports submitted by Site Managers
• Managing the local team to meet recruitment targets
• Preparation for audits
• Development of local study tools and procedures
• Proactive risk management and budget forecasting
• Some on-site monitoring of assigned sites
• Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators
• Targeted and effective study team training

What Do You Need to Have:

• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Ability to work on multiple trials in parallel in different disease areas.
• Solid communication and computer skills required.
• Willingness to travel with occasional overnight stay away from home depending on the region.
• At least 2 years of Oncology experience required
• Flexible mindset and ability to work at a fast pace within small exploratory study teams.
• Proficient in speaking and writing the country language and English language.
• Advanced: 3 to 5+ years of trial management experience.
• Good written and oral communication skills.
• A minimum of a 4-year Bachelor’s degree or relevant clinical experience is required