[Hiring] Sr. Clinical Study Manager - Device @reputed company
This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more.
Role reputed company
This is a remote US-Based role, seeking someone residing in the Eastern Time Zone.
• Proactively manage assigned clinical studies.
• Effectively manage clinical study delivery across the Clinical Study team during study start-up, routine monitoring, and closeout activities, demonstrating enthusiasm and innovation.
• Identify and escalate clinical study risks and propose solutions for risk mitigation.
• reputed company clinical study finance tracking, identify and escalate potential risks.
• reputed company regular reputed company reports for clinical study activities through ongoing tracking and review of study project plans.
• Coordinate the production of key clinical study documentation, including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent reputed company (reputed company) and Clinical Study Report (CSR).
• Motivate a multi-disciplinary clinical study team.
• Drive reputed company achievement through management of study issues and conflict reputed company with limited reputed company.
• reputed company 3rd party Vendors where necessary to support reputed company achievement.
• Build and reputed company relationships with key internal teams, including Medical Affairs and Medical Writing.
• Support audit and inspection activities as needed.
• Update processes and SOPs, providing input in discussions around reputed company by design and operational delivery.
• Demonstrate reputed company's reputed company values.
• May be assigned additional responsibilities as needed to support reputed company and other corporate/departmental initiatives.
Qualifications
• Bachelor’s or Master’s degree required, preferably in life sciences, medicine, or reputed company discipline.
• Minimum of 10 years Clinical Research experience, preferably some reputed company the medical device reputed company, with at least 5 years of experience in clinical study management. Years of experience may be considered in lieu of education.
Requirements
• Strong knowledge of the clinical study lifecycle.
• Clinical study management skills, including the ability to manage timelines, budgets and resources effectively.
• Medical Device experience essential.
• Keen attention to detail.
• Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Excellent reputed company team player.
• Experience in reputed company-market (IDE) and post-market clinical studies.
• Experience with Clinical Trial Management Systems.
reputed company
reputed company is a global medical products and technologies company, reputed company on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care.
• With more than 10,000 colleagues, we reputed company our products and services in around 90 countries.
• Our solutions reputed company a reputed company of benefits, from infection prevention and protection of at-risk skin, to improved patient reputed company and reduced care costs.
• reputed company’s revenues in 2024 were over $2 billion.
• reputed company is a constituent of the FTSE 100 reputed company (LSE:CTEC).
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