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Senior Clinical Data Manager (Mexico)

9 hours, 6 minutes ago
Mexico
Full-time
Lead
Database Administrator
Database Administration
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 102

Description

  • Serve as the primary data management contact and lead for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely execution.
  • Oversee the data entry process, including developing data entry guidelines, training, quality oversight, and resourcing.
  • Manage timelines and resource needs to ensure clinical data management deliverables are completed on schedule and with quality.
  • Develop CRF specifications from study protocols and coordinate review and feedback from stakeholders.
  • Build and test clinical databases, including conducting user acceptance testing and maintaining quality-controlled build documentation.
  • Define and oversee edit check specifications and manual data review specifications.
  • Create, revise, version, and maintain data management documentation and oversee Trial Master File completeness.
  • Train clinical research personnel and ensure data management project team members are adequately trained.
  • Review, query, and perform line listing data review of clinical trial data in accordance with the Data Management Plan.
  • Perform medical coding, coordinate SAE/AE reconciliation, and run patient- and study-level status and metric reports.
  • Liaise with external vendors and communicate with sponsors, project teams, and stakeholders on data and database issues.
  • Identify, troubleshoot, and resolve operational issues using metrics, audit reports, and stakeholder input.
  • Support SOP and process documentation development and maintenance for data and database management activities.
  • Participate in strategy meetings, bid defenses, capability presentations, proposal reviews, and project estimate preparation.
  • Provide leadership for cross-functional and organization-wide initiatives and may present software demonstrations or training sessions.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 8+ years of experience, or an equivalent combination of qualifications and relevant experience.
  • Professional-level English proficiency, both written and oral.
  • 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, representational, leadership, and interpersonal skills.
  • Ability to undertake occasional travel.
  • Experience in a clinical, scientific, or healthcare discipline (preferred).
  • 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 (preferred).

Benefits

  • Remote work is indicated by the posting (#LI-REMOTE).
  • Opportunity to help build the foundation of clinical data operations in Mexico.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and California applicant privacy notice provided for applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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