In this role, as the Clinical Trial Manager, you will have responsibility for leading cross-functional clinical teams in the design, planning, and execution of clinical studies in support of the Peripheral Interventions Interventional Oncology global business objectives for product development and/or commercialization.
• Leads and drives the project team in the planning, execution, and management of all operational aspects of Oncology clinical trials.
• Leads, directs, and executes worldwide Oncology clinical studies and/or programs, including first in human studies, in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
• Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
• Interacts and collaborates with physicians from diverse specialties
• Ensures the project team maintains a continuous state of audit readiness.
• In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
• Informs and presents study progress and known risks to Senior Leadership.
• Provides clinical input to product development activities.
• Bachelor’s degree in a health science field
• 5+ years of clinical research experience
• 3+ years of Oncology clinical research experience
• Experience managing study finances and budgets, financial acumen
• 3+ years of project management and leadership experience
• Experience managing global vendors such as CROs
• Participation on a product development (PDP) core team representing Clinical
• Maintain strategic perspective and independently implement action plans and align activities with project, program, and business objectives without significant supervision
• Respond flexibly and positively under conditions of uncertainty or change
• Ability to work collaboratively and cross-functionally with team members
• Strong organizational skills
• Ability to work under tight deadlines
• Excellent problem-solving skills
Position Overview The primary role of the Therapy Manager is to provide first class clinical training and education to current...Apply For This Job
For more information contact Robert Lauer: Robert@gatewayrecruiting.com...Apply For This Job
Job Description: Responsible for executing Peripheral Interventions global clinical strategy through the design, planning, execution and leadership of clinical studies and...Apply For This Job
Key Responsibilities: Leads development and authoring of program-level and study-specific regulatory documents, including protocols, protocol amendments, Investigator’s Brochures, clinical study...Apply For This Job
JOB DESCRIPTION:In this role, as the Clinical Trial Manager, you will have responsibility for leading cross-functional clinical teams in the...Apply For This Job