Clinical Data Management Specialist II

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.
1. Roehrborn, Can J Urol 2017

 

Position 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.

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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