Senior Associate, Clinical Trial Operations (Gene Therapy)

TL;DR

Senior Associate, Clinical Trial Operations (Gene Therapy): Providing operational support to clinical study teams to manage multiple phase clinical trials with an accent on compliance with FDA, GCP, and ICH guidelines. Focus on Trial Master File (TMF) management, CRO oversight, and executing study start-up activities.

Location: Remote (Global)

Salary: $113,000 - $143,500 Annual

Company

Global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage multiple clinical trials across all phases, ensuring adherence to protocols, SOPs, and FDA/ICH/GCP regulations.
• Support study start-up, patient recruitment, maintenance, and closure activities.
• Maintain and oversee Trial Master File (TMF) quality, conduct periodic QC checks, and report metrics.
• Coordinate CRO/vendor contractual documents, work orders, and amendments via procurement systems.
• Facilitate investigator meetings and serve as the primary liaison for the Medical Review Committee.
• Conduct monitoring and oversight activities to support ongoing clinical trial execution.

Requirements

• Bachelor's degree in healthcare, life sciences, or a related field.
• 3+ years of experience in Clinical Operations on the sponsor side or 5+ years at a CRO.
• Hands-on monitoring experience and deep understanding of clinical research processes and FDA requirements.
• Extensive experience with eTMF (specifically Veeva) and the DIA TMF Reference Model.
• Proven ability to manage budgets, purchase orders, and payment tracking for external parties.
• Strong communication and conflict management skills for collaborating with global cross-functional teams.

Nice to have

• Experience in rare disease and/or orphan indications.
• Demonstrated ability to train and mentor new hires and colleagues.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage, including mental health support.
• 401(k) plan with competitive company match and annual equity awards.
• Generous paid time off, fertility/family-forming benefits, and caregiver support.
• Access to Company Learning Institute, LinkedIn Learning, and leadership programs.
• Flexible work schedules and active Employee Resource Groups.