Manager, Clinical Data Management

Expected Travel: Up to 10%

Requisition ID: 11087 

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™, QuikClot™, LMA™, Pilling™, 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.

Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Manager, Clinical Data Management executes operational objectives, policies, procedures, and work plans for the development of clinical study databases. As an integral member of the Clinical Operations team, this position manages data management activities and interfaces with the rest of the Clinical Operations team to ensure that standards are communicated properly, timelines are met according to objectives and goals, data reporting needs are scheduled, and addressed, and the quality of data management deliverables are monitored. Ability to interact collaboratively and cross-functionally, in external partnerships and oversee CROs is a critical responsibility. Knowledge of Industry and regulatory standards with an ability to translate clinical team objectives into operational actions maximizing the current technical platforms will be a critical skill set.

Principal Responsibilities

•    Responsible for management of the clinical database vendor (Veeva Vault) in collaboration with the Clinical Operations team.
•    Maintain the operational objectives for the EDC system used by Clinical Operations and Global Scientific Affairs.
•    Support the development of policy and procedures for data management activities supporting EU MDR data collection goals.
•    Manages data activities for all clinical trials as well as the design, review, and validation of the clinical database to deliver data for analysis in compliance with standard operating procedures, and regulatory agency guidelines.
•    Design case report forms (CRFs) as well as data edit checks in collaboration with Clinical Operations.
•    Responsible for the development of any clinical database (including by an EDC/CRO vendor) and will manage the user acceptance testing (UAT) of the clinical database.
•    Manage vendors providing safety services while ensuring the accuracy of safety data and reports and maintaining compliance with associated committee charters.
•    Contribute to the development and implementation of data management department policies, standards operating procedures. Recognize potential obstacles and partner with team members to resolve them within set timelines.
•    Proactively identifies potential challenges, risks, and opportunities related to the data management function and strives to achieve best-in-class data management performance for all business units and regions.
•    Perform implementation of data functions for new business.
•    Participate in audits of internal files and external vendors.
•    Management and oversight of data management personnel.
•    Implement methods to support individual and team development.
•    Perform other duties as assigned.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
 

Education / Experience Requirements

•    Bachelor’s degree in a technical or clinical field, or equivalent related work experience in the respective field.
•    Minimum of four years of relevant work experience to include data management of clinical studies.
•    Previous experience leading teams or managing direct reports required.
•    Proficiency using Veeva Vault, electronic data capture systems, Excel, and Access 
•    Expertise in case report form design and data validation using Electronic Data Capturing sys