Manager, Clinical Operations
Teleflex

Job Info

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Expected Travel: Up to 25%

Requisition ID:4157

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Interventional Urology - NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract's focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

*No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

1. Roehrborn, J Urology 2013 LIFT Study
2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

The Manager, Clinical Operations is responsible for leadership and execution of clinical studies in support of the direction and goals of the Company. As an integral member of the Clinical Operations team, this position is responsible for supporting daily activities of their team members in order to ensure all projects are completed on time, in budget, and in compliance with all standards. In addition, this position develops and assesses SOPs and reviews processes for efficiency and compliance. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research and urology.

Principal Responsibilities

• Responsible for selecting, training, and developing a team comprised of Clinical Project Managers, CRAs, or a mixture of roles
• Promotes quality and performance standards for clinical trial administration and works to ensure they are documented and understood by the entire team
• Acts as a liaison with other managers in order to assess staff allocation and identify team members available for potential studies
• Oversee a cross-functional clinical study team including developing timelines, budgets, resources planning and risks associated with assigned projects.
• Lead the development of study protocols and associated documents as the project lead and clinical operations subject matter expert.
• Ability to independently manage all phases of a clinical study including essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
• Manage study meetings to ensure completion of established project team goals and objectives.
• Ability to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct and adherence to ICH guidelines and provides risk mitigation solution.
• Assess trends in data including adverse events, protocol violations, etc. and provide study status updates to Management team and develop sufficient resolution of identified action items.
• Contribute to clinical reports, data management, data analysis, and publications.
• May also oversee qualification, site initiation, interim and close-out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations, as needed.
• Develop and assess SOPs.
• Monitor emerging trends to help integrate new requirements into department procedures.
• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
• Participate in department systems and development initiatives, including related trainings.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Operations team in general and with various improvement projects.
• Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

• Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.
• At least 7 years of clinical research experience, medical device experience preferable
• At least 3 years of experience managing direct reports

Specialized Skills / Other Requirements

• US IDE and OUS experience highly preferred, post-market study experience is desirable.
• Strong interest in and ability to mentor direct reports in all aspects of clinical trial management
• Knowledge of urology and BPH disease state preferred.
• Maintain credentialing requirements at hospitals and clinics as needed.
• 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-levels with limited supervision and effectively partner with team members when necessary.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• Proficient in Microsoft Word, Excel, and Access and the ability to quickly learn other software tools and applications.
• Ability to develop strong relationships with investigative sites.
• Ability to travel up to 25% to perform training and monitoring.
• Valid driver's license issued by the state in which the individual resides.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose.Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.

© 2021Teleflex Incorporated. All rights reserved.

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