Clinical Project Manager

Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

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:

This position will manage clinical research projects, including key activities of landmark, global clinical trials, in a fast-paced environment with a focus on planning, execution and management of all operational aspects. Interfaces with the VP and Director, Clinical Affairs, and senior managers to provide tactical/operational leadership to members of the clinical study team, including cross-functional departments which support the clinical development process.

[e.g., Clinical Research Associates (CRAs), Regulatory Affairs, Medical Affairs, Scientific Affairs, Biostatistics, Statistical Programming, Medical Writing, Data Management, Quality Assurance, Safety]. ESSENTIAL FUNCTIONS OF THE POSITION:
Leads, executes, and monitors progress and performance of assigned clinical studies and programs globally, in accordance with strategy, project plans, and budget following applicable regulatory and standard operating procedures. Oversees the development of and collaborates with the study team on key team trial deliverables, such as protocols, informed consent documents, case report forms, trial guidelines, annual progress reports and final reports, including sponsor required regulatory submissions.

Drives identification, qualification, and selection of clinical sites. Ensures clinical studies maintain a continuous state of audit readiness. Leads proactive identification, assessment, and management of clinical study risks. Informs and presents study progress and known risks to senior leadership. Selects and manages ongoing relationships with external vendors (i.e., CROs, core labs, central IRB, etc.) or contractors. Oversees contracts & other agreement for all aspects of assigned clinical studies.

Oversees development of Clinical Monitoring Plan(s) and adequate monitoring of clinical study sites. Responsible for the conduct of site trial training and investigator meetings. Provides support to clinical investigators and site coordinators to resolve site-related issues. Manages day-to-day project activities of CRAs assigned to specific projects & provides project direction. Manages escalation of study related issues and establishes appropriate course of action/mitigation plans.

Ensures adequate clinical data collection and follow-up compliance. Participates in study data review and interpretation, as well as oversight of clinical report writing. Thorough understanding of project management tools/techniques. Serves on various teams & represents the clinical department as needed. Participates in departmental developmental initiatives (e.g., training, SOP development, audit preparedness, etc.) Comprehensive knowledge of ISO (International Organization for Standardization), GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA (Food & Drug Administration) & other applicable…