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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Clinical Data Manager

Job Description

  • Location: Naples, Florida
  • Type: Direct Placement
  • Job #76734
  • Salary: $170,000 Annually

Our client, a global medical devices company is hiring a Manager of Clinical Data.

Work Location: Naples, FL (hybrid)

Main Objective: 

  • Responsible for leading and growing the Clinical Data Management Team and the day-to-day operational activities of data management for clinical studies.
  • Lead the development and maintenance of software utilized for data collection.

Essential Duties and Responsibilities:

  • Provides leadership in developing best practices for measuring and optimizing clinical data management initiatives.
  • Subject matter expert for clinical data management systems.
  • Supervise Clinical Data Management Team by establishing responsibilities, empowering their Individual Development Plan, and providing ongoing mentoring.
  • Creates and enforces effective database build and data management processes in EDC, CTMS, and eTMF systems.
  • Oversee the study-specific database build using study protocol and configuration specifications.
  • Enforces compliance with project and data management plans for data handling and sharing with the clinical research team.
  • Lead User Acceptance Testing (UAT)
  • Supports clinical research team, clinical data team sites in the daily use of data systems and ensures adherence to legal and company standards.
  • Supervises adequacy and documentation of data management training internal and external stakeholders.
  • Enforce the edit checks and manual listing review activities according to study specifications.
  • Supervise ongoing query review with closures of system-generated queries at least monthly and before monitoring visits.
  • Supervise the distribution of data reports, extracts, and other deliverables as defined in the data management plan.
  • Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning, and locking.
  • Lead and coordinate the creation of study-specific eCRF instructions.
  • Assures databases and archives are protected from security breaches and losses.
  • Lead the troubleshooting activities for data-related problems and provide maintenance or authorizes modification.
  • Lead QC functions activities – using edit checks, data listings, and other available tools/reports, manage quality control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables. 
  • Lead data cleaning and delivery activities – manage clinical data cleaning and delivery activities and include database lock. 
  • Develop and maintain data management standard operating procedures, work instructions, and training documents
  • Leads distribution of interim metrics reports to key stakeholders.

Education and Experience: 

  • Bachelor’s degree required, preferably in business, life science or computer science.
  • Master’s degree preferred.
  • Ten years of clinical research data management experience required.

Knowledge and Skill Requirements/Specialized Courses and Training: 

  • Thorough knowledge of ICH guidelines, FDA Regulations, and GCP, including international regulatory requirements for conducting clinical development programs, especially related to data handling and processing, is required. 
  • Prior trial responsibility of the entire data management life cycle is desirable.
  • Experience in medical device trials is preferred.
  • Working knowledge of EDC studies are required.
  • Good knowledge of the Clindex system is preferred.
  • Ability to communicate effectively with peers, cross-functional partners, and internal and external stakeholders.
  • Ability to work effectively with little supervision and strong attention to detail in a team environment.
  •  Ability to work effectively on multiple projects at the same time.
  • Individual must be highly motivated and self-directed. 
  • Excellent written and verbal communication skills.
  • Comprehension of medical terminology or can reference literature for understanding is required.
  • Proficient software skills: Word/ Excel/ PowerPoint/database is required.

Machine, Tools, and Equipment Skills:

  • PC, Clindex database, SOS, research tools, internet research tools.
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