Clinical Data Management Specialist
Teleflex

Job Info

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Expected Travel: None

Requisition ID:3782

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

As an integral member of the Clinical Operations team, the Clinical Data Management Specialist supports all Clinical data management functions within timeline and quality objectives, from study launch through close-out. With oversight from management, this position partners to develop and execute data management plans (DMPs), and builds and validates EDC, including eCRF design. This position requires a strong knowledge of EDC, experience in clinical trials and related regulations, and the ability to perform at a high level in a fast-paced, dynamic environment.

Principal Responsibilities

• Manage study data in various phases in high volume, from planning through closeout.
• Manage ongoing data cleaning, data locks, and supporting data analysis.
• Execute project plans for EDC build, including interim and final analysis, and build eCRFs and program logic.
• Conduct DMP and EDC training to internal teams and sites, and develop and update training manuals.
• Organize ongoing data review to ensure the highest caliber data, on time, in conjunction with monitoring and data locks.
• Maintain systems for device accountability, site payments, and media tracking.
• Follow and maintain study master files per procedures.
• Recognize process improvement needs and proactively implement efficient solutions, including SOPs and WI development.
• Partner with management to manage external vendors, including ongoing supplier qualification and accountability.
• Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
• Work on assigned projects.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!

Education / Experience Requirements

• Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
• 1 - 3 years of clinical data management or other relevant experience.
• Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently.
• Mastery of Excel.
• Experience working under US and international clinical regulations and guidance.
• Experience with building studies using Electronic Data Capturing systems, both out-of-box and custom.

Specialized Skills / Other Requirements

• Experience working under US and international clinical regulations and guidance.
• Experience with building studies using Electronic Data Capturing systems, both out-of-box and custom.

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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