Senior Clinical Trials Operations Lead (Remote)

NewAmsterdam Pharma Corporation; Pennsylvania; On-site; USD 120,000 - 160,000; Full time

Job summary

NewAmsterdam Pharma Corporation is looking for an Associate Director, Clinical Trial Management to oversee and ensure the successful execution of clinical trials. This role involves coordinating trial activities, managing documentation, and ensuring compliance with regulatory standards.

The ideal candidate will have over 5 years of clinical trial operations experience, a Bachelor's degree in a scientific discipline or as an RN, and proficiency in CTMS and MS Office. This position is remote based in the Northeast US, with travel required.

Qualifications

• 5+ years Phase 1-3 global clinical trial operations experience.
• Demonstrated experience managing external vendors/CROs.
• Advanced knowledge of GCP, ICH and FDA regulatory requirements.

Responsibilities

• Support planning, execution, and closeout of clinical trials.
• Coordinate clinical trial operational activities.
• Manage clinical trial documentation and data integrity.

Skills

Project management

Clinical trial operations

Vendor management

Collaboration

Data integrity

Education

Bachelor’s degree in a scientific discipline or RN

Tools

Clinical trial management systems (CTMS)

MS Office

Job description

NewAmsterdam Pharma Corporation is looking for an Associate Director, Clinical Trial Management to oversee and ensure the successful execution of clinical trials. This role involves coordinating trial activities, managing documentation, and ensuring compliance with regulatory standards.

The ideal candidate will have over 5 years of clinical trial operations experience, a Bachelor's degree in a scientific discipline or as an RN, and proficiency in CTMS and MS Office. This position is remote based in the Northeast US, with travel required.