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Clinical Oversight Lead

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. The company is advancing a growing clinical and preclinical stage product pipeline. For more information, visit www.inovio.com.

Job summary

This is an office based role working with Clinical Project Leads on priorities such as issue investigation and resolution at the site level, CAPA implementation, and inspection preparation.  The role will involve a significant amount of sponsor oversight activities including on-site assessment of CRAs and central, risk based review of study metrics.  This person will work at a high level, on quality related issues, across multiple projects and indications.

Essential job functions and duties

  • Work with Clinical Project Leads to investigate and resolve issues at clinical sites or with CROs, initiating and facilitating CAPA plans as required
  • Remote eCRF data and study metrics review for early identification of confusing CRFs, consistent data entry errors, delayed data entry, excessive deviations, etc.
  • Assist Inovio and clinical sites in preparation for inspections
  • On-site CRA assessments
  • Some domestic and international travel required (estimated at approx. 30%)

Minimum requirements

  • Bachelor’s degree in life science or healthcare, or nursing qualification and experience
  • Oncology and/or Infectious Disease experience (Immuno-oncology or Vaccine experience preferred)
  • 5+ years of monitoring sites in relevant disease indications

Essential requirements

  • Site management skills, including issue resolution and negotiation
  • Successful experience implementing and monitoring CAPA plans
  • Prior experience working with sites to prepare for Regulatory Authority inspections
  • Experience with multiple EDC platforms, including remote monitoring
  • Ability to multi-task and interact at multiple levels in a growing, fast paced organization
  • Thorough knowledge of ICH-GCP and FDA/EMA regulations (ISO guidelines and device experience a plus)
  • Results driven, with excellent communication skills, and ability to work independently
  • Prior experience monitoring, extrapolating and implementing data from a Risk Based Management software tool to improve quality project oversight (preferred)

 

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.

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