Genetic Medicine Operations Specialist

1 week ago


San Jose, California, United States Cedent Consulting Inc Full time

Cedent Consulting Inc. is seeking a highly experienced Senior Clinical Research Associate Consultant to support the clinical operations strategy for our CF program.

About Us

We are a leading consulting firm dedicated to providing expert guidance in clinical operations and rare diseases.

Job Description

This role requires substantial experience in rare diseases or genetic medicines, such as mRNA, gene therapy, or gene editing.

Key Responsibilities:
  • Support the Clinical Operations Study team in ensuring timely and efficient trial initiation and completion.
  • Assist with CRO activities, including site feasibility, qualification, initiation, and interim monitoring.
  • Develop or assist in the creation of trial materials and activities for identifying rare disease patients.
  • Collaborate with the Clinical Operations Program Lead, providing training to CRO and site staff.
  • Track, monitor, and present key study performance metrics to the cross-functional team.
  • Manage delegated trial processes from the Clinical Operations Study team.
  • Review data listings for accuracy, oversee data discrepancy management, and provide training/retraining to site staff and CRAs as needed.
  • Coordinate with CRO and vendors on start-up activities, including ethics submissions.
  • Escalate issues promptly to the Clinical Operations Program Lead and Head of Clinical Operations.
  • Foster strong working relationships with the study team and clinical trial sites.
  • Travel as needed for site initiation and co-monitoring visits.
Qualifications:
  • Bachelor's degree required, with 4+ years of experience in clinical operations across Phase 1-3 trials.
  • Preferred experience in rare diseases or orphan drugs.
  • Demonstrated knowledge of ICH GCP guidelines and clinical monitoring procedures.
  • Experience working with clinical trial vendors, including CROs, imaging, home health, and patient recruitment.
  • Strong organizational skills and ability to manage multiple projects simultaneously.
  • Excellent communication and interpersonal skills, effective in cross-functional environments.
  • Creative problem-solving abilities, especially for rare disease programs.
  • Ability to champion change in a dynamic environment.
Salary Information

$120,000 - $160,000 per year, depending on experience.



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