Clinical Data Management Specialist

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $100.5k - $150.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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Teleflex

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $275k Venture Round on 2010-01

Healthcare Insurance • Medical Devices • Pharmaceuticals

Teleflex is a global provider of innovative medical devices and solutions, dedicated to supporting healthcare professionals and enhancing patient care. With a diverse portfolio that includes products for anesthesia, emergency medicine, interventional cardiology, and more, Teleflex aims to improve the health and quality of lives. The company emphasizes its commitment to education and customer support in the healthcare sector.

📋 Description

• Review and contribute to the authorship of protocols and other study documentation, promoting consistency across and within the 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 systems such as Veeva CDMS Vault (or equivalent EDC platforms). • 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 and validation for in-house studies, accounting for Interim Analysis, abstract deliverables, and 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 Contract Research Organization (CRO) Data Management Plans, CRF Completion Guidelines, external data transfer agreements, and other study documentation as applicable. • 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!

🎯 Requirements

• Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or a relevant field of study; or equivalent experience. • Minimum of two years of Clinical Data Management or other relevant experience, preferably within the medical device industry. • Advanced proficiency in Excel for complex data review and reconciliation. • Experience working under US and international clinical regulations and guidance (ISO 14155, GCP, and 21 CFR Part 11). • Experience with building studies using Electronic Data Capturing systems, both out-of-the-box and custom. • Understanding of business process improvement and the tools and data requirements for supporting an effective business process improvement practice. • Preferred: Familiarity with clinical data standards (e.g., CDISC, CDASH) to support regulatory submissions.

🏖️ Benefits

• medical • prescription drug • dental • vision insurance • flexible spending accounts • participation in a 401(k) savings plan • various paid time off benefits, such as PTO • short- and long-term disability • parental leave