Manager, Clinical Data Management (Remote, US)

Date: Aug 5, 2022

Location: San Diego, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6701

 

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

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 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. 

**Position can be based remotely, within the US.**

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. 
•    Designs 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 4  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 systems
•    Experience working under US and international clinical regulations and guidance

Specialized Skills / Other Requirements

•    Strong organizational, communication and documentation skills, proven ability to review and coordinate the collection of data and related documentation for research studies  
•    Ability to make independent decisions and take responsibility for own actions within a fast-moving environment.
•    Understanding of business process improvement and the tools and data requirements for supporting an effective business process improvement practice
•    Ability to collaborate effectively and participate in a team environment
•    Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. 
•    Excellent verbal and written communication skills, including presentation skills
 

 

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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: San Diego