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.

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.

Clinical Project Manager II

Key skills