Senior Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteTeam 5,001-10,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$128.8K - $180.3K / year

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• Accountable for driving timely and high-quality data management deliverables supporting the Olympus portfolio • Designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure integrity of clinical data • Oversees application of industry standards, data review and query management • Accountable for quality study dataset release and consistency for submission data • Serves as a key liaison between clinical operations, biostatistics, and external vendor • Responsible for leading data management responsibilities for several concurrent clinical trials • Utilizes the electronic data capture and management systems • Manages trials in various stages, from planning, to start-up, conduct, closeout, and archiving • Assists in the design and implementation of clinical data management processes with vendors • Ensures completeness, correctness, and consistency according to Siemens standards • Collaborates with the Biostatistics and Clinical Operations team members, and other functions as applicable

Job Requirements

  • BS degree in a Biomedical Science or comparable field of study
  • Bachelor's degree with a minimum of 8 years of global clinical data management experience, or a Master’s degree with a minimum of 6 years of experience
  • Prior experience in a sponsor, CRO, or medical device company
  • In-depth knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA
  • Strong expertise in implementing and maintaining systems for global trials (Specifically, Medidata Rave)
  • Proven leadership in managing full-cycle data management activities
  • Experience with risk mitigation and data quality strategies
  • In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP
  • Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products)
  • Excellent stakeholder management skills with cross-cultural sensitivity and global collaboration experience
  • Strong experience in vendor management and system validation
  • Excellent verbal and written communication skills and interpersonal skills
  • Excellent analytical, organizational, and communication skills
  • Ability to manage multiple priorities in a fast-paced environment
  • Proficiency with clinical data systems and MS Office Suite
  • Position may require some travel
  • Candidates must be authorized to work in the U.S.
  • Occasional meetings out of normal working hours will be required as this role supports a global team

Benefits

  • Competitive salaries, annual bonus and 401(k) with company match
  • Comprehensive medical, dental, vision coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free live and on-demand Wellbeing Programs
  • Generous Paid Vacation and Sick Time
  • Paid Parental Leave and Adoption Assistance
  • 12 Paid Holidays
  • On-Site Child Daycare, Café, Fitness Center

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