Clinical Project Manager II

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. The Clinical Project Manager II will lead a clinical sleep study, ensuring regulatory compliance and driving collaboration to deliver high-quality results.

Responsibilities:

• Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project
• Apply principles, concepts and techniques for effective and proactive project management of a clinical study
• Balances resource constraints (i.e. time, money, people, and equipment) against deliverables
• Develop clinical study budget and may assist in quarterly departmental budget reviews
• Seeks input from higher-level clinical experts or program management as issues warrant
• Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department
• Implement and maintain risk-based monitoring processes to drive efficient and effective study management
• Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance
• Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance

Requirements:

• Bachelor's or advanced degree in a relevant scientific discipline
• 3-5 years of medical device clinical project management experience
• Experience with sleep and respiratory studies are required
• In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety
• Ability to proactively develop risk management and mitigation plans in country and resolve issues locally
• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills
• High sense of accountability and urgency to prioritize deliverables
• Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal
• Ability to focus on multiple deliverables and protocols simultaneously is essential
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Able to directly influence Clinical Operations staff