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Clinical Operations Excellence Specialist

1 month ago


Cambridge, Massachusetts, United States Lifelancer Full time
Company Overview

Sarepta Therapeutics is a pioneer in genetic medicine, holding leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs). With over 40 programs in various stages of development, the company is at the forefront of gene therapy, RNA, and gene editing. Sarepta's commitment to patients and dedication to innovation drive its mission forward.

Job Summary

We are seeking a highly skilled Clinical Operations Excellence Specialist to join our team. This remote position will report to the Senior Manager, Clinical Operations Excellence and provide subject matter expertise to facilitate optimal clinical development operations, GCP compliance, and trial oversight.

Key Responsibilities
  • Support Development Operations with SOP reconciliation, development, and management to ensure accuracy and compliance;
  • Provide CTMS support and develop implementation of process improvement initiatives to ensure efficiency and consistency within the Development Operations and compliance with GCP;
  • Participate in transformative initiatives that create effective and efficient processes that meet high compliance standards, collaborating across Development Operations;
Required Skills and Qualifications
  • Experience in supporting clinical trial GCP compliance/quality management activities;
  • Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely;
  • Ability to work independently and manage deadlines;
  • Excellent interpersonal and communication skills (both written and oral) including ability to develop strong relationships with both internal and external customers in a matrix environment;
  • Problem-solving, process improvement, analytical, and collaborative skills;
  • Self-motivated, calm under pressure, and adaptable to a dynamic environment with the ability to support successful change;
  • Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, ICH-GCP guidelines, International Council for Harmonization E6(R2) guidelines, and other applicable major Health Authority regulations;
Benefits
  • A competitive salary range of $112,000 - $140,000 per year;
  • A comprehensive benefits package designed to support physical and emotional wellness, financial wellness, and caregiver support;
  • Ongoing opportunities for professional growth and development;
  • A chance to work with a talented team of professionals who share a passion for innovation and excellence;
About Lifelancer

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, health sciences, healthtech, data science, and IT domains.