[Hiring] Clinical Data Management Specialist @Teleflex

Role Description

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. 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 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 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.
• 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!

Qualifications

• 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.

Requirements

• Ability to make independent decisions and take responsibility for one's 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 is preferred.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies.
• Must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Ability to read, understand, and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions, and report on findings.
• Adaptable and welcoming of change and willingness to explore and implement process improvements.
• Experience in leading by influence.
• Skills in complex analytic problem solving.
• Ability to recognize potential obstacles and work to resolve them within set timelines.
• Strong interpersonal and relationship-building skills.

Benefits

• Medical, prescription drug, dental, and 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, and parental leave.