Senior Clinical Data Manager

Company: ReCor Medical Inc.
Location: Palo Alto
Posted on: November 19, 2021

Job Description:

Senior Clinical Data Manager The Senior Clinical Data Manager (CDM) is responsible for the coordination and delivery of Data Management services, project plan timelines, processes and standards on assigned studies. The Senior Clinical Data Manager is responsible for providing study specific data management oversight, providing standard data management services (data cleaning and query), supporting project timelines, process and standards. They are responsible for ensuring that clinical data management best practices are followed. They should be able to effectively communicate with internal stakeholders, CROs and vendors as required. Additionally, as the primary point of contact they should be able to facilitate and provide data management updates in project team meetings.Role and Responsibilities - Assist with or independently develop data management plans that deliver accurate, timely, and consistent clinical data. Build, review, and maintain clinical databases, data collection tools, and applications. - Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs). - Contribute to protocol development and review. Compile, analyze, clean, and validate clinical trial data. Identify and resolve discrepancies and issues with clinical data. - Develop data management reports and monitor study status to ensure timelines are met. Represent the data management function to key internal and external stakeholders. - Design and Program outputs to be able to identify, analyse and interpret trends and patterns in complex data sets. Identify and resolve discrepancies within the clinical data set - Work collaboratively with clinical research and operations team to ensure accurate and complete data collection. - Working knowledge of statistical programming packages (e.g. R, S, SAS, SPSS) - Considered highly skilled and proficient in discipline. Advanced individual contributor. Conducts complex, important work under minimal supervision and with wide latitude for independent judgment.Education Requirements Minimum of Bachelor's degree in Health Sciences, Life Sciences, Mathematics, Computer Sciences, or a related discipline (or International equivalent). Relevant work experience may be considered in absence of degree.Experience - 5 years relevant experience in a CRO, Pharmaceutical or Medical Device Company for entry level Clinical Data Manager. 3+ years for Senior Data Manager - Exposure to statistical programming packages (e.g. R, S, SAS, SPSS) - Senior level positions expected to understand principals of ICH, GCP, ISO 14155; Project Management; Vendor Management; MedDRA and WHO Drug coding & CDISC standards - Effective written and verbal communication - Well organized and detail oriented - Ability to handle multiple projects and prioritize effectivelyJob Type: Full-timePay: $120,000.00 - $125,000.00 per yearBenefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insuranceSchedule:
  • Monday to FridaySupplemental Pay:
    • Bonus payAbility to commute/relocate:
      • Palo Alto, CA 94303: Reliably commute or planning to relocate before starting work (Preferred)Application Question(s):
        • Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?Education:
          • Bachelor's (Preferred)Experience:
            • Clinical Data Management: 5 years (Preferred)Work Location: One location

Keywords: ReCor Medical Inc., Palo Alto , Senior Clinical Data Manager, Executive , Palo Alto, California