[Hiring] Clinical Project Manager II @ClinChoice
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Role Description
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 is a remote W-2 position on a one-year contract.
• 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.
• Applies 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.
• Develops clinical study budget and may assist in quarterly departmental budget reviews.
• Seeks input from higher-level clinical experts or program management as issues warrant.
• Leverages experience and works with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department.
• Implements and maintains risk-based monitoring processes to drive efficient and effective study management.
• Oversees and reviews data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively addresses violations/deviations, to assure protocol and GCP compliance.
• Trains and mentors more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance.
Qualifications
• 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.
Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Apply Now
Apply Now
Role Description
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 is a remote W-2 position on a one-year contract.
• 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.
• Applies 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.
• Develops clinical study budget and may assist in quarterly departmental budget reviews.
• Seeks input from higher-level clinical experts or program management as issues warrant.
• Leverages experience and works with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department.
• Implements and maintains risk-based monitoring processes to drive efficient and effective study management.
• Oversees and reviews data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively addresses violations/deviations, to assure protocol and GCP compliance.
• Trains and mentors more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance.
Qualifications
• 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.
Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Apply Now
Apply Now