Contract Clinical Operations Lead

PTC Therapeutics, Inc.; Warren Township (IA); On-site; USD 83,000 - 110,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Contract, Clinical Operations professional to lead the execution of clinical trials across one or more indications.

You will collaborate with cross-functional teams to manage trial design, site selection, budgeting, and regulatory submissions to meet timelines and compliance. Responsibilities include developing study protocols, coordinating with sites and CROs, and maintaining trial oversight using GMP/GCP standards.

Qualifications

• Bachelor’s degree in a scientific discipline with 7+ years of clinical research experience.
• Knowledge of GMP, GCP, and ICH guidelines.
• Experience in protocol development and regulatory submissions.
• Strong written and verbal communication; able to work in a matrix team.

Responsibilities

• Leads planning, execution, and reporting of clinical trials, including timelines, CRF design, site selection, and study reporting.
• Interacts with internal and external teams to shape clinical strategies and trial design.
• Assists in literature evaluation, protocol development, and preparation of regulatory documents.
• Manages timelines and budgets, reviews trial data, and supports regulatory submissions.

Skills

Clinical research

Regulatory knowledge

Data analysis

Cross-functional

Education

Bachelor’s degree in science

Tools

MS Word

MS Excel

MS Project

PowerPoint

Job description

PTC Therapeutics, Inc. is seeking a Contract, Clinical Operations professional to lead the execution of clinical trials across one or more indications.

You will collaborate with cross-functional teams to manage trial design, site selection, budgeting, and regulatory submissions to meet timelines and compliance. Responsibilities include developing study protocols, coordinating with sites and CROs, and maintaining trial oversight using GMP/GCP standards.