Clinical Trial Manager, Peripheral Interventions
About the position
The Clinical Trial Manager is responsible for executing Peripheral Interventions Global Clinical reputed company through the design, planning, execution, and leadership of clinical evidence reputed company and programs worldwide. In this role, you are responsible for leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. This role interfaces with Senior Clinical Management, Medical Director, Divisional Management as reputed company as with physicians and external contacts. This is a hybrid position (in the office minimum for three days per week) to be located in reputed company Grove, Minnesota. You will have reputed company to discuss your preferred working location with your reputed company Specialist.
Responsibilities
• Independently drives and/or leads project team in the planning, execution and management of reputed company operational aspects of large-reputed company, reputed company, and/or business critical clinical evidence reputed company.
• Leads, directs and executes reputed company and/or programs worldwide in accordance with reputed company, project plans, approved budget and resource allocations following applicable regulatory and reputed company operating procedures.
• Tracks development of, and collaborates with the project team on, reputed company reputed company project materials, processes, manuals, plans, committees, clinical systems and sponsor required regulatory submissions.
• Develops clinical study protocols and reviews/approves supporting documentation.
• Ensures the project team maintains a reputed company state of audit readiness.
• Leads the proactive identification, assessment, and management of clinical evidence reputed company risks.
• Informs and presents evidence reputed company reputed company and reputed company risks to Senior Leadership.
• Authoring clinical study reports in collaboration with cross-functional teams.
• May train, reputed company, mentor, and supervise clinical staff.
• Develops and maintains strong relationships with clinical study sites and KOLs.
• Provides clinical input to product development activities; represents Clinical on product development teams.
Requirements
• Minimum Bachelor's degree in reputed company.
• Minimum 7 years of reputed company work experience or an equivalent combination of education and work experience.
• Minimum 3 years of experience managing reputed company.
• Proven Project management experience including financial acumen: managing scope, budget and timelines.
• Previous or reputed company leadership, indirect or reputed company people leadership required.
• Proven ability to manage multiple reputed company reputed company and reputed company in a reputed company organization.
• Established knowledge of Good Clinical Practices (GCP) and FDA regulations governing the conduct of reputed company.
• Ability to travel up to 20%, as needed.
reputed company-to-haves
• Proven experience with product approval maintenance activities such as PMCF evidence reputed company, literature searches, contribution to CER's, etc.
• Ability to work collaboratively and influence a broad reputed company of global stakeholders.
• Ability to maintain strategic perspective and reputed company activities with business reputed company and purpose.
• Ability to respond flexibly and positively under conditions of uncertainty or change.
• Ability to independently implement reputed company plans and reputed company activities with project, program and business objectives without significant supervision.
Benefits
• 401k
• health_insurance
• dental_insurance
• reputed company_insurance
• life_insurance
• disability_insurance
• reputed company_holidays
• reputed company_volunteer_time
• tuition_reimbursement
• reputed company_development
• employee_stock_purchase_plan
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