Clinical Trial Manager - Investigator Initiated Studies

Job Responsibilities

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks.
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development.
• Conducts study start-up activities including leading study kick off meetings, contract management, and site onboarding and training.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) as needed to ensure compliance with study requirements and GCPs.
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management.
• Track internal and external project deliverables to ensure they remain within the timeline and budget.
• Perform other duties as required for successfully completing studies, as necessary.

Skills Needed

• Ability to work in a smaller team environment with a willing, all hands-on deck attitude.
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities.
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects.
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required.
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint