Clinical Project Manager
3 weken geleden
Clinical Project Manager
Amsterdam, Netherlands Req #2109 Thursday, June 6, 2024 As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator Synergy Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients’ worldwide.We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
Position Summary:
The Clinical Research Project Manager will oversee the planning, execution, and management of all operational aspects of clinical research projects. This role involves providing tactical and operational leadership to the clinical study team, collaborating with cross-functional departments, and ensuring the successful completion of clinical trials in accordance with regulatory and company standards.
Essential Functions:
Lead, execute, and monitor progress and performance of assigned clinical studies and programs globally, ensuring alignment with strategy, project plans, and budget. Oversee the development of key team trial deliverables, including protocols, informed consent documents, case report forms, trial guidelines, and regulatory submissions. Drive the identification, qualification, and selection of clinical sites. Ensure clinical studies maintain a continuous state of audit readiness. Proactively identify, assess, and manage clinical study risks. Inform and present study progress and known risks to senior leadership. Select and manage relationships with external vendors (, CROs, core labs, central IRB). Oversee contracts and other agreements related to clinical studies. Develop and oversee Clinical Monitoring Plans and ensure adequate monitoring of clinical study sites. Conduct site trial training and investigator meetings. Provide support to clinical investigators and site coordinators to resolve site-related issues. Manage day-to-day project activities of CRAs and provide project direction. Manage escalation of study-related issues and establish appropriate mitigation plans. Ensure adequate clinical data collection and follow-up compliance. Participate in study data review and interpretation, as well as oversight of clinical report writing. Serve on various teams and represent the clinical department as needed. Participate in departmental developmental initiatives (, training, SOP development, audit preparedness).Basic Qualifications:
Bachelor’s degree in a science or related technical field. Minimum of 6 years of related work experience or an equivalent combination of education and work experience. At least 2 years of experience managing medical device clinical trials. Broad knowledge and cross-functional understanding of clinical trials methodology and team deliverables. Excellent oral and written communication skills. Proficiency in Microsoft Office and Microsoft Project. Strong written/report writing skills. Problem-solving and troubleshooting experience. Ability to travel up to 40% depending on the phase of study execution.Join AtriCure:
If you are passionate about advancing medical research and making a difference in patient outcomes, we invite you to apply for the Clinical Research Project Manager position at AtriCure. Join our team of dedicated professionals and contribute to our mission of developing innovative medical solutions.
What we offer:
With AtriCure, you'll get the opportunity to work with a team that is passionately dedicated to improving the lives of patients with Atrial Fibrillation worldwide. It is also a company that will invest in your professional development to help you grow and be successful in your role.
In addition, AtriCure also provides:
Our Process:
Please apply through LinkedIn or on our website. We would like to get to know you better so please feel free to share ample information about yourself and why you are interested in working with us. Once we have your application, our International Recruiter will contact you to find out more about your background and your expectations. The next steps include a meeting with the hiring manager to focus on key information about the role and to potential fit into the team. If this round is successful, you will get to meet a few of our team members to give you diverse perspectives about AtriCure. After all the interviews, we conduct reference checks to help us make the final decision.#LI-MW1
Other details
Job Family Clinical Development Job Function Clinical Pay Type Salary Employment Indicator Non Manager Travel Required Yes Travel % 40 Share this job:-
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