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Senior Clinical Data Manager

2 hours, 4 minutes ago
Taiwan
Full-time
Senior
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 52

Description

  • Serve as the primary data management contact and lead for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely execution.
  • Oversee the clinical trial data entry process, including data entry guidelines, training, quality checks, and resourcing.
  • Develop CRF specifications from study protocols and coordinate stakeholder review and feedback.
  • Build or support clinical databases, conduct database build user acceptance testing, and maintain controlled build documentation.
  • Define and oversee edit check specifications and manual data review specifications.
  • Create, revise, version, and maintain data management documentation, including Trial Master File completeness.
  • Train clinical research personnel and data management team members on study-specific CRFs, EDC systems, and other project materials.
  • Review and query clinical trial data, perform line listing reviews, and run patient- and study-level status and metric reports.
  • Perform medical coding and coordinate SAE/AE reconciliation.
  • Liaise with external vendors, sponsors, and project teams to manage timelines, data issues, and deliverables.
  • Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
  • Participate in protocol, SAP, and CSR review as needed and support SOP/process documentation development.
  • Provide leadership for cross-functional and organization-wide initiatives and contribute to bid defenses, proposals, estimates, and capability presentations.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 8+ years of experience in clinical data management or related clinical research work.
  • Ability to handle a variety of clinical research tasks.
  • Excellent organizational and communication skills.
  • Professional written and oral English skills.
  • Experience using various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
  • Strong leadership, representational, and interpersonal skills.
  • Hands-on systems knowledge of Medidata Rave and Veeva.
  • Ability to undertake occasional travel.
  • Experience in a clinical, scientific, or healthcare discipline (preferred).
  • Experience with dictionary medical coding tools such as MedDRA and WHODrug (preferred).
  • Understanding of CDISC standards such as CDASH, SDTM, and ADaM (preferred).
  • Oncology and/or orphan drug therapeutic experience (preferred).
  • Knowledge of biostatistics (preferred).

Benefits

  • Opportunity to work for a growing organization in the Asia Pacific region.
  • Equal opportunity employer status.
  • Reasonable accommodation support for candidates with disabilities during the application process.
  • Privacy policy and applicant privacy notice protections for submitted data.

Interested in this position?

Apply directly on the company website

Apply Now

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