Clinical Data Management Leader

3 days ago

Redwood City, California, United States Lifelancer Full time

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.

The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Job Opportunity

A reputable company in the medical devices sector is seeking an experienced Clinical Data Management Leader to join their Clinical Affairs team.

This role will be responsible for developing and implementing clinical data management strategies, processes, and standards for all phases and activities of clinical investigations.

The ideal candidate will have a depth of knowledge and experience with industry standards compliance and all applicable local and international regulations to ensure high-quality data.

This is a remote opportunity for qualified candidates in the United States.

Key Responsibilities
  • Provide leadership, strategic planning, direction, and implementation of clinical systems for data collection, including vendor selection, budgeting, resource planning, vendor oversight, EDC build, and study timelines.
  • Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHODrug; complete database lock, archival, and closeout activities.
  • Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks.
  • Provide study-level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities.
Requirements
  • Bachelor's Degree in a scientific discipline required; Master's degree or above preferred.
  • Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
  • Minimum of 5+ years in a clinical research setting, preferably at the Sponsor.
  • Experience overseeing multiple, global clinical trials as a CDM from database build to database lock.
  • Expert-level knowledge and experience in CDM in all study phases and activities from startup to archival with at least 1 year in a lead role for clinical development programs with medical devices leading toward FDA filing/approvals.
  • Pulmonary industry or clinical knowledge preferred but not required.
  • Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development, and testing, discrepancy management, data quality review, and database close and lock procedures, CDASH, and SDTM data formats.
  • Working knowledge of GCP, ICH, and FDA guidance and regulations for clinical trials.
  • Working knowledge of MedDRA and WHODrug dictionary coding terms.
Compensation

$150,000 - $175,000/year depending on experience.

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