GCP Clinical Quality Specialist/Senior Specialist

GCP Clinical Quality Specialist/Senior Specialist

It takes a team to reach the summit.

Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.

Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers has an opening for experienced Clinical Quality Specialist.

This position will initially report to the Chief Medical Officer (CMO) with a strong partnership with the Quality organization, you will provide technical support to the Clinical Development team and work with CROs engaged in clinical trials. Using your knowledge of Good Clinical Practices, you will help to ensure that department activities along with external partnership are compliant and operating as outline in study protocols.

Job Responsibilities:

  • Provide technical expertise and assistance on Clinical Practices and Trials
  • Review and understand Clinical Trial protocols and the requirements and exceptions established for third party vendors/providers including service level agreements.
  • Perform quality evaluations (QE) and reviews of early phase clinical study Trial Master File (TMF) documentation
  • Manages and tracks study Quality Issues (QI), supporting Operations staff with root cause analysis (RCA), and implementing CAPAs
  • Work with Regulatory staff to ensure agreements and contracts are in place for all providers.
  • Assist as directed, with site and provider audits, compiling all documentation for analysis.
  • Reviews audit results, identify and recommend remedial actions to the team.
  • Assist with management with clinical database and ensure associated records are in order.
  • Track functional project activities and trails to ensure they are meeting expected timelines and deliverables. Advise management of approaching deadlines and if additional resources are required to meet goals.
  • Other duties as assigned.

Required Skills & Qualifications:

  • (6) years of experience in clinical quality, clinical supply project management or related role/expertise in pharma and/or biotech.
  • Bachelor’s degree in life science or related area required. Advanced degree preferred.
  • Advanced Microsoft Suite skills/experience required
  • Strong written and verbal communication skills and highly organized with the ability to meet deadlines, excellent attention to details.
  • Must maintain confidentiality at all times.
  • Proven success working well under pressure in a fast-paced and rapidly growing environment with continued process improvement and change
  • Able to thrive in a remote/virtual environment

Up to 20% domestic travel may be required. Must be located within and authorized to work in the United States today and in the future.

Life at Elevation Oncology

Our values lay the foundation for the road ahead:

INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.

COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.

ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.

If you share our beliefs and are interested in helping to further our mission, send your resume or CV to careers@elevationoncology.com and tell us how you would. We look forward to meeting you!

Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.