- Location: Naples, Florida
- Type: Direct Placement
- Job #77830
- Salary: $120,000 Annually
- Supervise clinical data professionals assigned to conduct data management activities for clinical studies.
- To supervise the preparation of data collection forms, database design, specification and testing, cleaning, locking, extracting, and reporting on study progress for internal and external stakeholders.
- Participate in data management strategies for regulatory and marketing initiatives.
- Participates in overall department strategy to provide clinical data for regulatory requirements, marketing, and reimbursement initiatives for new and existing products.
- Supervises Data Management Team
- Manages resource assignments across projects.
- Assess the competency of the Data Management Team to satisfy position responsibilities and evaluate their performance.
- Provides expert review and advice for the creation of Data Management deliverables, including electronic Case Report Forms (eCRFs), database design and specification, User Acceptance Testing (UAT), study-specific eCRF instructions, Data Management Plan (DMP), data cleaning, database lock, reports, and extracts.
- Enforces processes for effective data management in an electronic database (EDC), electronic trial master files (eTMF), electronic patient-reported outcomes (ePRO), and Clinical Trial Management System (CTMS)
- Provide advice and solutions to issues to improve efficiency.
- Monitor quality and efficiency across projects to identify trends and improvement opportunities.
- Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning, and locking.
- Assures databases and archives are protected from security breaches and losses.
- Develop and maintain data management standard operating procedures, work instructions, and training documents.
- Master's degree preferred. Preferably in business, life science, or computer science.
- Bachelor's degree required. Preferably in business, life science, or computer science.
- Seven years of clinical research data management experience preferred.
- Two years of supervisory experience required.
- Clinical or Data Management Certification is required or obtained in two years.
- Through knowledge of guidelines and regulations 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 and eTMF is required.
- Ability to supervise and mentor team.
- Ability to lead multiple projects at the same time.
- Individuals 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: Microsoft Office/ Word/ Excel/PowerPoint/database is required.
- PC, laptop, and printer.
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Clinical Data Supervisor - Naples, United States - TSR Consulting
Description
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 Supervisor
Job Description
Work Location: Naples, FL
Main Objective:
