Senior Clinical Trial Associate (Biopharmaceutical)

TL;DR

Senior Clinical Trial Associate (Biopharmaceutical): Providing operational support to clinical study teams to manage multiple clinical trials across all phases with an accent on regulatory compliance and Trial Master File (TMF) management. Focus on ensuring adherence to GCP and FDA standards, coordinating with CROs, and maintaining inspection readiness.

Location: Hybrid (Bridgewater, New Jersey)

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 operational support for clinical trials across the full lifecycle from start-up through closure.
• Ensure strict compliance with SOPs, FDA regulations, GCP, and ICH guidelines.
• Execute QC activities for Sponsor- and CRO-supported TMF, maintaining high levels of inspection readiness.
• Coordinate study materials, training matrices, and documentation tracking for the clinical study team.
• Collaborate with CROs and third-party vendors to execute studies and review contractual documents and invoices.
• Assist in study operations planning, risk assessment, and mitigation strategies using RACT tools.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field.
• Minimum 3 years of progressive experience in a Clinical Operations role within biopharma, CRO, or ARO.
• Strong knowledge of clinical research processes, medical terminology, and FDA regulatory requirements.
• Proven experience with eTMF (Veeva preferred) and a solid understanding of the DIA TMF Reference Model.
• Experience managing budgetary and financial practices, including purchase orders and payment tracking.
• Must be based in or be able to work from the Bridgewater, New Jersey office.

Nice to have

• Experience in rare disease and/or orphan indications.
• Proactive approach to assisting colleagues and supervisors.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match, annual equity awards, and ESPP.
• Generous paid time off, fertility/family-forming benefits, and caregiver support.
• Access to Company Learning Institute, LinkedIn Learning, and leadership programs.
• Flexible work schedules combined with purposeful in-person collaboration.