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Clinical Data Manager II/Senior Clinical Data Manager

3 weeks ago
United States
Full-time
Senior
Database Administrator
Database Administration
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 106

Description

  • Serve as the primary data management contact for assigned clinical projects or programs and ensure continuity and timely execution of tasks.
  • Oversee the project data entry process, including data entry guidelines, training, data quality, and resourcing.
  • Develop CRF specifications from the clinical study protocol and coordinate stakeholder review and feedback.
  • Conduct database build user acceptance testing and maintain quality-controlled database build documentation.
  • Oversee the overall quality of the clinical database and assist with clinical database builds as needed.
  • Specify and oversee edit check requirements, including electronic, manual data review, and related specifications.
  • Create, revise, version, and maintain data management documentation for the Trial Master File.
  • Train clinical research personnel and data management team members on study-specific CRFs, EDC, and project processes.
  • Review, query, and line-list clinical trial data in accordance with the Data Management Plan and sponsor guidance.
  • Coordinate SAE/AE reconciliation, medical coding, reporting, and vendor communications to support data deliverables and timelines.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 8+ years of experience as a Senior Clinical Data Manager and 5 years as a Clinical Data Manager II.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, and Outlook.
  • Experience using various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
  • Excellent organizational, communication, leadership, interpersonal, and representational skills.
  • Professional written and oral English communication skills.
  • Ability to handle a variety of clinical research tasks and occasional travel.
  • Preferred: experience in a clinical, scientific, or healthcare discipline.
  • Preferred: dictionary medical coding experience with MedDRA and WHODrug.
  • Preferred: understanding of CDISC standards such as CDASH, SDTM, and ADaM.
  • Preferred: oncology and/or orphan drug therapeutic experience.

Benefits

  • Competitive salary range of $91,500 to $166,100 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance, retirement savings benefits, life insurance, and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
  • 100% remote work with preference for candidates on the East Coast.
  • Equal opportunity employer with accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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