The Clinical Trial Manager (CTM) will be responsible to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Additionally, you will communicate and document all interactions with client as required by SOP.

Essential Responsibilities Include:

• Serve as client advocate and primary point of contact for client, functional leads, and vendors on assigned studies
• Organizes and leads meetings as appropriate
• Develop and implement Clinical Monitoring Plan
• Coordinate and oversee daily operations of clinical operations team on one or more studies
• Coordinate site management activities:
• Site identification, feasibility, and selection
• Regulatory document collection and review
• Overall scheduling and management of all site visits
• Develop site/monitoring tools and training materials
• Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
• Manage project milestones and proactively address deficiencies
• Define and implement functional standards, goals, and expectations with clinical monitoring team and serve as mentor
• Set and enforce project timelines and review clinical data
• Oversee monitoring visit schedule to ensure compliance
• Manage quality and regulatory compliance among clinical monitoring team and investigational sites
• Review project budgets, monitoring costs, potential overruns, and propose/implement cost effective solutions
• Prepare audit responses and preparation of information for client reports
• Define the scope of work, and identify and generate changes in scope; notify client of potential changes in scope
• Assure that the appropriate Pharmaron and/or sponsor SOPs are followed
• Ensure all project documentation is appropriately filed per SOPs
• Support organizational growth and development

Qualifications:

• BS/BA Degree (or equivalent) in relative field with 5+ years of relative experience
• Or MS Degree (or equivalent) in relative field with 3+ years of relative experience
• Candidate should have experience in clinical studies, preferrable in Oncology
• Minimum of 3 years as a successful Clinical Trial Manager at a CRO preferred