Senior Clinical Trial Lead and Associate Director

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

Job summary

Scholar Rock, Inc. is seeking a Senior Clinical Trial Manager to oversee all operational aspects of clinical studies from setup through final reports, with support from leadership. The role may coordinate several clinical team members and external vendors, and may serve as in-house Lead CRA when needed.

The position requires coordinating start-up, site and CRO activities, budget management, and regulatory compliance, with travel up to 20%. This is a full-time on-site role in Cambridge, MA.

Qualifications

• BS/BA degree in a scientific discipline; advanced degree preferred.
• Minimum of 5+ years demonstrated experience in a biotech/pharmaceutical/CRO company, clinical research site or related healthcare company.
• Prior experience with a multi-phase clinical program or experience across multiple phases of clinical drug development.
• Highly organized, outcome oriented, self-motivated performance.
• Thrives in a fast-paced and evolving environment.
• Excellent interpersonal skills with stakeholders across disciplines; strong negotiation skills.
• Understanding of the drug development process and regulatory requirements (GCP/ICH).

Responsibilities

• Implement clinical project plans aligned with protocols, timelines, and regulatory objectives.
• Facilitate internal project team meetings and drive study start-up including CRO selection.
• Act as point of contact for sites, vendors and CROs and monitor adherence to scope of work.
• Manage interactions with investigators and sites to ensure compliance with regulatory requirements.
• Identify and escalate issues jeopardizing timely study completion; support budget and contract reviews.
• Participate in audits of vendors, sites and CROs; support site monitoring visits.
• Plan and present Investigator Meetings and other key meetings; develop reporting tools for leadership.

Skills

Project management

Regulatory knowledge

GCP/ICH familiarity

Budget management

Vendor management

Cross-functional leadership

Communication

Education

BS/BA in a scientific discipline

Advanced degree preferred

Job description

Scholar Rock, Inc. is seeking a Senior Clinical Trial Manager to oversee all operational aspects of clinical studies from setup through final reports, with support from leadership. The role may coordinate several clinical team members and external vendors, and may serve as in-house Lead CRA when needed.

The position requires coordinating start-up, site and CRO activities, budget management, and regulatory compliance, with travel up to 20%. This is a full-time on-site role in Cambridge, MA.