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Associate Trial Manager

New Jersey All, NJ

Posted: 01/09/2019 Job Type: Clinical Job Number: JN -012019-23357
  • In collaboration with the Clinical Trial Manager will contribute to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs
  • Candidates must have experience working on global, sponsored trials in a study management/clinical operations role
  • Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors
REQUIRED EDUCATION AND EXPERIENCE:
  • Completed BA/BS in directly-relevant discipline or equivalent experience
  • At least 4 years experience as CTA or experience in the CORE TASKS listed below in a Pharmaceutical company or CRO
  • Clinical Operations experience required
  • Oncology experience preferred
REQUIRED CORE TASKS:
  • Review of monitoring visits reports (Required)
  • ICF review (Required)
  • CRO oversight or has worked on outsourced studies (Required)
  • Writing study team minutes or running study team meetings (Required)/CRA meetings do not qualify all functional teams need to be present at meeting
PREFERRED CORE TASKS:
  • Vendor/site payments (Preferred)
  • IP Recon (Preferred)
  • Experience working with IVRS/EDC for data pulling/reports (Preferred)
Responsibilities involve a combination of execution and oversight, dependent upon the sourcing model, to ensure study deliverables are met and may include, but are not limited to, the following:
  • Provide operational input on development, management and maintenance of study plans and tools
  • Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
  • Monitoring visit report review
  • Informed Consent review
  • Support Health Authority inspections and CQA audits
  • Ensure full compliance (of the required data in study management tools)
  • Proactive identification of potential risks and development/implementation of actions
  • Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
  • Manage Trial Master File set-up, ongoing quality review, and final reconciliation
  • Reconcile IP at study level in collaboration with IMSC
  • Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes
  • Contribute to development / coordination of study training for study team, investigational sites, and vendors
  • Manage vendor and site payment processing and tracking
  • May perform other assigned tasks as required
SKILLS / KNOWLEDGE REQUIRED:
  • Strong oral and written skills with proficiency in English
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Analytical approach and anticipation of problems
  • Ability to multi-task effectively and prioritize assignments from multiple sources
  • Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
  • Excellent organizational skills
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
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