Clinical Project Manager II

ClinChoice

4h

About The Position

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is seeking a Clinical Project Manager II to partner with one of our sponsors in leading a clinical sleep study. This role requires demonstrated experience managing medical device clinical trials, with a strong preference for respiratory study experience. The ideal candidate will bring expertise in overseeing study execution, ensuring regulatory compliance, and driving cross-functional collaboration to deliver high-quality results on time and within scope. This role is a w-2 contract role.
ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts.

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.

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.

What This Job Offers

• Career Level: Mid Level