Associate Director & Senior Clinical Trial Manager

Lever, Inc.; Cambridge (MA); On-site; USD 155,000 - 225,000; Full time

Job summary

Scholar Rock in the United States (MA) seeks a Senior Clinical Trial Manager to oversee all operational aspects of clinical studies from setup to final report, with support from Clinical Operations leadership. The role may coordinate CRAs, Data Managers, vendors, and investigators, and may serve as Lead CRA for a study.

Travel up to 20% may be required; strong regulatory knowledge is essential. BS/BA in science and 5+ years in biotech/pharma settings are required; an advanced degree is a plus.

Qualifications

• BS/BA in a scientific discipline is required; an advanced degree preferred.
• Minimum 5+ years of experience in biotech/pharmaceutical/CRO or related healthcare company.
• Experience with multi-phase clinical programs or across multiple phases of drug development.
• Highly organized, outcome-oriented, self-motivated and capable of fast-paced work.
• Excellent interpersonal, written and oral communication skills.
• Understanding of the drug development process and GCP/ICH guidelines.

Responsibilities

• Implement clinical project plans aligned with protocols, timelines, and regulatory objectives.
• Facilitate internal project team meetings and coordinate CROs, vendors and sites.
• Lead study start-up activities including CRO selection and budget management.
• Monitor adherence to scope of work, QA processes, and regulatory requirements.
• Prepare and present status updates at Investigator Meetings and leadership reviews.
• Travel up to 20% as needed.

Skills

Project management

Interpersonal skills

Communication skills

Analytical thinking

Problem solving

Education

BS/BA in scientific discipline

Advanced degree preferred

Job description

Scholar Rock in the United States (MA) seeks a Senior Clinical Trial Manager to oversee all operational aspects of clinical studies from setup to final report, with support from Clinical Operations leadership. The role may coordinate CRAs, Data Managers, vendors, and investigators, and may serve as Lead CRA for a study.

Travel up to 20% may be required; strong regulatory knowledge is essential. BS/BA in science and 5+ years in biotech/pharma settings are required; an advanced degree is a plus.