Medvaconlifesciences

Development Business Operations Associate

Foster City, CA, United States · Contract

Sponsorship not specifiedDetected 1288 days ago
GCPRESTData ScienceData VisualizationProject ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipPublic Speaking

About the role

  • MEDVACON Life Sciences works with many leading pharmaceutical companies to hire consultants, contractor's and full-time employees to join their organizations.
  • One of our pharmaceutical clients is looking to fill a Development Business Operations Associate position ON-SITE in Foster City, CA.
  • This is a HYBRID position, worked two days per week in office, and the rest is worked remotely.

Responsibilities

  • Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements
  • Collaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the records management/TMF archival initiative
  • Work with management to manage business continuity procedures, including management of paper agreements
  • Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing
  • Collaborate with management to generate central intake report on a daily and published in a timely fashion
  • File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing
  • Work with management to develop and maintain quality assurance and control plans
  • Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management

Requirements

  • 3plus years of data science experience with common data science toolkits and data visualization tools

Nice to have

  • 3-5 plus years of relevant experience
  • 5 plus years of project management experience with PMP preferred
  • 3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
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This listing is sourced directly from Medvaconlifesciences's careers page and normalized into a canonical job model.