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Remote Manager, Clinical Data Team (remote)

Remote
Company Location: Anywhere
arthrex-inc
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Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

**This position in based in Naples, FL. Remote optional for the right candidate. If remote, travel required to Naples headquarters quarterly for 1 week**

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Manager of Clinical Data. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

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.

#LI-IS1

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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