Teleflex

The CRA Manager will lead a team of Clinical Research Associates, overseeing study activities from site selection to close-out. This role involves ensuring compliance with regulations and maintaining data integrity while aligning deliverables with corporate goals. | Candidates should have a Bachelor of Science degree and a minimum of 8 years of clinical research experience, including at least 3 years in a management role. Proficiency in Microsoft Office and knowledge of US and international clinical regulations are also required. | Expected Travel: More than 50% Requisition ID: 13046   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™, QuikClot™, Rüsch™, UroLift™ 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 teleflex.com.   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 GuideLiner™ 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 international clinical regulations and guidance documents.•    Participate in department systems and development initiatives including related trainings.•    Support investigator meetings as needed.•    Support Protocol Deviation and Adverse Event review and reporting.•    Maintain credentialing requirements at hospitals and clinics as needed.•    Complete projects and tasks consistent with corporate objectives.•    Support the Clinical Operations team in general and with various improvement projects.•    Perform other duties as assigned.Education / Experience Requirements •    Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.•    Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity.•    Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc.•    US IDE, IND, and OUS experience preferred.Specialized Skills / Other Requirements •    Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.•    Excellent time management skills.•    Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.•    Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.•    Ability to perform at high-level with limited supervision and effectively partner with team members when necessary.•    Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.•    Ability to develop strong relationships with investigative sites.•    Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.•    Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.•    Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.  CULTURE:•    Customer Experience – Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers. •    Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. •    Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 50-75% (US and Internationally)  The pay range for this position at commencement of employment is expected to be between $125,700- $188,600 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.   #LI-LM1At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.   Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.   Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™,  LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2025 Teleflex Incorporated. All rights reserved.

The Regional Clinical Research Associate will conduct on-site and remote monitoring visits for clinical studies, ensuring compliance with regulatory standards. Responsibilities include evaluating protocol compliance, data accuracy, and subject safety, as well as collaborating with site staff to resolve compliance concerns. | Candidates should have a Bachelor's or Graduate degree in life sciences or a related field, along with a minimum of five years of experience as a CRA in the medical device or pharmaceutical industry. Specialized knowledge in vascular interventional cardiology and current certification as a CCRA or CCRP is preferred. | Expected Travel: More than 50% Requisition ID: 12724   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™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ 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 teleflex.com.   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 GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. 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 TRAVEL REQUIRED: 70%  The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies and procedures) for assigned clinical studies in the field of vascular intervention or other therapeutic areas.Principal Responsibilities •    Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicable. •    Responsible for all monitoring activities for assigned clinical studies, including:o    Scheduling and conducting monitoring activities onsite or remote within specified timelines and according to the risk-based monitoring plan and Teleflex procedures. o    Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem-solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. o    Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriate.o    Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits, and proactively provides input on site performance.o    Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution.  o    Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparation. o    Trains and mentors Teleflex personnel on monitoring procedures and practices.o    Conducts site training and co-monitoring visits as requested by management.o    Completes monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex procedures. o    Assists with team, department, and study-related projects as requested, including audits, investigator meetings, training, etc.o    Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilities.Education / Experience Requirements •    Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines.•    Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.Specialized Skills / Other Requirements •    Demonstrated aptitude and knowledge in relevant therapeutic area. Vascular Interventional Cardiology is strongly preferred. •    Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. •    Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials.•    Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). •    Strong knowledge of medical terminology•    Ability to work independently in a regional area with minimal supervision•    Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. •    Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. •    Ability to interact constructively in communication of adherence to protocol and regulatory requirements.•    Responsible for adequate and reasonable home office setup including dedicated desk space to accommodate work responsibilities and Teleflex-supplied equipment. CULTURE:•    Customer Experience – Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers. •    Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. •    Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 70%    The pay range for this position at commencement of employment is expected to be between $105,000- $115,000  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.   Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.   Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.  © 2025 Teleflex Incorporated. All rights reserved.