Clinical operations – Senior Clinical Trial Manager

Job Description

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. Our therapeutic pipeline consists of immuno-oncology programs against novel drug targets we discovered computationally, including T cell immune checkpoints and additional early-stage immune-oncology programs focused largely on myeloid targets. As we advance our pipeline, we are looking for a senior clinical trials manager to oversee the day to day operations of the clinical trials.

  • Work independently and oversee the successful execution of phase 1/2 studies from startup across the clinical program
  • Provide oversight of CROs and work collaboratively with a cross functional team (clinical and non-clinical) across the company
  • Drive clinical studies including identifying and communicating study-related challenges that will impact budget, resources and/or timelines
  • Prior experience with developing budgets, review of invoices, contracts with vendors is a plus

Job Requirements

  • Bachelor’s Degree – A degree in a health-related discipline is preferred
  • 3+ years of relevant experience in pharmaceutical industry, prior experience in immuno-oncology is preferred
  • Prior experience with developing budgets, review of invoices, contracts with vendors is a plus
  • Working knowledge and experience with EDC platforms, IVRS, Microsoft Word, Power point, Excel
  • Knowledge of regulations (e.g., GCP, ICH) governing the conduct of clinical trials
  • Prior experience leading or actively participating in SIVs and site monitoring
  • Experience providing guidance and oversight of CROs, including managing clinical trials from startup
  • Excellent working knowledge of clinical trial financials including budget review and analysis
  • Highly effective team player with exceptional interpersonal skills building relationships with clinical trial sites
  • Experience with developing and reviewing clinical protocols, data query and line listing reviews, contributing to study-related documents such as IB, pharmacy manual
  • Ability to work independently with little oversight and attention to detail and results oriented
  • Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches
  • Excellent oral and written communication skill
  • This position requires travel 20%

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