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Senior Clinical Data Manager - FULLY REMOTE

Company: SDC (Statistics & Data Corporation)
Location: Miami
Posted on: June 25, 2022

Job Description:

SDC is a collection of diversified professionals who are committed to providing experienced teams who will take ownership of client needs and are positively engaged in projects. We provide top-tier clinical trial services to pharmaceutical, biotechnology, and medical device/diagnostic companies since 2005. Our global team operates in the highest quality of ethics and sustainability by adopting our clients' needs as our own and delivering exceptional results. We view ourselves as a valued partners to our clients and our proven track record of success has allowed us to grow year over year.Our commitment to our clients is the same commitment to our employees. By offering strong benefits, focused career development, and a flexible schedule we can attract and employ some of the most talented people in the industry. Energy, Integrity, Engagement, Innovation, Ownership, and Commitment are our core values and the backbone of our culture at SDC.Take a look at how you can join our team!About the Role:Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. Manages the day-to-day data management project activities including, but not limited to timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Managers and Clinical Data Analysts.Requirements

  • Exceptional working knowledge of clinical trials and the data management role in the clinical trials process
  • Excellent organizational and project management skills
  • Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
  • A minimum of 3 years of staff mentoring and leadership experience
  • Outstanding leadership capabilities
  • Strong delegation abilities
  • Highly effective written and verbal communication skills in English
  • Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
  • Desirable skills include: CRF design, MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events and medical therapies)
  • Experience in multiple therapeutic areas (TAs) in clinical trials is mandatory including experience in at least two of the following TAs: ophthalmology, oncology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterologyEducation Or Equivalent Experience
    • Master's degree (preferably in engineering, applied or life science) and at least four (4) years of experience in clinical data management including leading several clinical studies, or
    • Bachelor's degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of five (5) years of experience in clinical trials, or
    • Current Certified Clinical Data Manager (CCDM) status and five (5) years of experience in clinical trials.BenefitsWhat you can expect from us:
      • Competitive wages
      • Flexible work schedules
      • Fully remote roles
      • Variety of therapeutic areas
      • Career advancements
      • Medical insurance
      • HSA with company match
      • Dental with 2 coverage options
      • Vision
      • 401K with company match
      • Paid Time off
      • Over 10 company holidays
      • Life Insurance
      • Inclusive and collaborative company culture
      • Identity theft protection
      • Voluntary accident and critical illness insurance

Keywords: SDC (Statistics & Data Corporation), Miami , Senior Clinical Data Manager - FULLY REMOTE, Healthcare , Miami, Florida

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