Clinical Data Manager

Expected Travel : None Requisition ID : 14183   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. 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 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.     Principal Responsibilities

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

Develop Electronic eCRFs, program edit/rule checks, query logic and generate database specifications using EDC.

Implements CDISC/SDTM standards within eCRFs to ensure compliance and data consistency.

Performs additional validation or data processing tasks using SAS programming.

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.

Oversee, review, and approve Data Management Plans, CRF Completion Guidelines, external data transfer agreements and other study documentation as applicable.

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.

Conducts regular reviews of clinical trial data in conjunction with monitoring teams and ensures compliance with GCP, 21 CFR Part 11, ISO 14155, and MDR requirements.  Education / Experience Requirements

Master’s degree preferred (e.g., in medicine, life sciences, natural sciences, mathematics, or computer science); Bachelor’s degree acceptable with relevant experience.

Two to three years of professional experience in clinical data management or a closely related field.

Proficiency in CDISC/SDTM implementation (is an advantage).

Programming knowledge in SAS, with working knowledge of SQL, R, and Python (is an advantage).

Experience developing and maintaining data validation plans and documentation.

Strong understanding of GCP, ISO 14155, MDR and 21 CFR