CPM - Medical Device

Job Title: Clinical Project Manager - Medical Device

Company Overview: My client is a leading provider of innovative medical devices dedicated to improving patient outcomes and advancing healthcare globally. With a commitment to excellence and a passion for innovation, we are seeking a talented Clinical Project Manager to join our dynamic team.

Position Overview: As a Clinical Project Manager at my client, you will play a crucial role in driving the successful execution of clinical trials for our cutting-edge medical devices. You will be responsible for overseeing all aspects of clinical project management, ensuring adherence to timelines, budgets, and regulatory requirements. This position offers a unique opportunity to contribute to the development and commercialization of groundbreaking medical technologies that have the potential to positively impact millions of lives worldwide.

Key Responsibilities:

1. Project Planning and Execution:

   • Develop comprehensive project plans, including timelines, milestones, and deliverables, in alignment with corporate objectives and regulatory requirements.
   • Lead cross-functional project teams to ensure the successful execution of clinical trials from initiation to completion.
   • Monitor project progress, identify potential risks or issues, and implement proactive solutions to mitigate challenges and ensure project success.

2. Regulatory Compliance:

   • Ensure compliance with all applicable regulatory standards, including FDA regulations, ISO requirements, and other relevant guidelines.
   • Collaborate with regulatory affairs teams to prepare and submit necessary documentation for regulatory approvals and maintain compliance throughout the clinical trial process.

3. Stakeholder Management:

   • Serve as the primary point of contact for internal and external stakeholders, including clinical investigators, contract research organizations (CROs), and regulatory agencies.
   • Foster strong relationships with key stakeholders to facilitate effective communication and collaboration throughout the project lifecycle.

4. Budget and Resource Management:

   • Develop and manage project budgets, tracking expenses and resource allocations to ensure efficient use of resources and adherence to financial goals.
   • Coordinate with finance and procurement teams to oversee vendor selection, contract negotiations, and procurement of necessary resources for clinical trials.

5. Data Management and Analysis:

   • Work closely with data management teams to ensure accurate and timely collection, analysis, and reporting of clinical trial data.
   • Review study data and collaborate with biostatisticians and clinical research associates to generate insights and conclusions to support decision-making.

Qualifications:

• Bachelor's degree in a relevant scientific or healthcare field; advanced degree (e.g., MS, PhD) preferred.
• Minimum of 2 years of experience in clinical project management within the medical device industry, with a strong understanding of clinical trial design, execution, and regulatory requirements.
• Proven track record of successfully managing complex clinical projects, including experience with budget management, timeline development, and risk mitigation.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Strong attention to detail and problem-solving abilities, with a demonstrated ability to manage multiple priorities in a fast-paced environment.
• Proficiency in project management tools and software applications (e.g., Microsoft Project, Excel, etc.).
• Certification in project management (e.g., PMP) and/or clinical research (e.g., CCRA, CCRC) preferred.

Join Our Team: If you are a highly motivated and results-driven professional with a passion for improving patient outcomes through innovative medical technologies, we invite you to apply for the position of Clinical Project Manager at my client. Join us in our mission to revolutionize healthcare and make a meaningful difference in the lives of patients worldwide.

Application Instructions: To apply, please submit your resume/CV and a cover letter outlining your qualifications and interest in the position. We thank all applicants for their interest; however, only those selected for an interview will be contacted.

My client is an equal opportunity employer and is committed to diversity in the workplace. We encourage applications from individuals of all backgrounds and experiences.