Clinical Research Associate Manager; REMOTE

Position: Clinical Research Associate Manager (REMOTE)
Expected Travel:
More than 50%

Requisition

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, Quik Clot, Rüsch, Uro Lift and Weck - trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our Guide Liner and Turnpike Catheters, Ringer Perfusion Balloon Catheter, AC3 Optimus and AC3 Range Intra-Aortic Balloon Pumps and the OnControl Powered Bone Access System.

Teleflex's product portfolio now also includes Passeo-18 Lux Peripheral Drug-Coated Balloon Catheter, Pantera Lux Drug-Coated Balloon Catheter, Orsiro Mission Drug-Eluting Stent, the PK Papyrus Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance.

This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research.

Principal Responsibilities

* Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth.

* Serve as primary point of contact for CRA escalations and issue resolution across assigned studies.

* Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.

* Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.

* Train site personnel regarding the protocol and applicable regulatory requirements.

* Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.

* Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review.

* Facilitate corrective action assessment and maintain TMF in BIMO readiness.

* Provide study status updates to Management team and develop sufficient resolution of identified action items.

* Contribute to annual reports, data management, data analysis, and publication support.

* Develop and assesses SOPs annually, as needed.

* Maintain current knowledge of applicable US and…