ClinChoice

Compensation

Full Description

Job Description: • 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. Benefits: • competitive salary • professional development opportunities