Clinical Data Management Specialist II

　　Date: Jan 16, 2024

　　Location: Morrisville, NC, US

　　Company: Teleflex

　　Expected Travel : None

　　Requisition ID :9318

　　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 – The Interventional Urology business unit of Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our flagship product, the UroLift® System, is the #1 minimally invasive procedure in the U.S. for treating an enlarged prostate, also called Benign Prostatic Hyperplasia, or BPH.* It is a proven approach that does not require heating, cutting, or destruction of prostate tissue.1 Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

　　*U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on data provided by Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.

　　Roehrborn, Can J Urol 2017Position Summary

　　As an integral member of the Clinical Operations team, the Clinical Data Management Specialist II supports all Clinical data management functions within timeline and quality objectives, from study start-up through close-out. With oversight from management, this position partners to develop and execute Data Management Plans (DMPs) and builds and validates Electronic Data Capture (EDC). This position requires 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.

　　#LI-LP1

　　Principal Responsibilities

　　• Review and contribute to the authorship of protocols and other study documentation promoting consistency across and within business unit.

　　• Effectively communicate Data Management requirements, strategies, timelines, and deliverables.

　　• Develop Electronic eCRFs, program edit/rule checks, query logic and generate database specifications using Veeva CDMS Vault.

　　• Lead the process for study team review of the following: eCRF Screen review(s), Edit/Rule review including EDC database specification process with study team(s).

　　• Create User Acceptance test scripts, execution logs for User Acceptance Testing (UAT) and engage the Study team for testing participation.

　　• Develop eCRF Completion Guidelines according to study design, promoting quality data.

　　• Develop and maintain the Data Management Plan (DMP) throughout the lifecycle of the study, ensuring the DMP is followed according to study design and requirements.

　　• Manage in-stream data cleaning, validation, for in-house studies, accounting for Interim Analysis, abstract deliverables, final database locks, while supporting data analysis and reporting.

　　• Generate study metric reports related to Query Management, site performance and SDV, but not limited to these activities.

　　• Coordinate data deliverables with the CRO for studies fully outsourced for Data Management.

　　• 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.

　　• Follow and maintain procedures for filing study files.

　　• Recognize process improvement needs and proactively implement efficient solutions, including SOPs and Work Instructions (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.

　　• Responsible for the set-up of the Trial Master File (TMF) and archiving artifacts throughout the study life cycle.

　　• 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 experience.

　　• 2 - 5 years of Clinical Data Management or other relevant experience.

　　• Ability to organize and multitask in a highly collaborative and cross-functional business units.

　　• Proficiency in Excel.

　　• Experience working under US and international clinical regulations and guidance.

　　• Ability to make independent decisions and take responsibility for own actions within a fast-moving environment.

　　• Experience with building studies using Electronic Data Capturing systems, both out-of-box and custom.

　　• Understanding of business process improvement and the tools and data requirements for supporting an effective business process improvement practice.

　　Specialized Skills / Other Requirements

　　• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies.

　　Language and Verbal Skills:

　　Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

　　Math Skills:

　　Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

　　Analytical and Reading Skills:

　　Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.

　　Physical Requirements:

　　The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

　　Work Environment:

　　Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

　　Safety:

　　NeoTract is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

　　Additional Information

　　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: 877-880-8588 or [email protected].

　　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.