Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:
The Unblinded Clinical Trial Manager is responsible for all unblinded operational aspects of a clinical study from setup through final report, with support from Clinical Operations Leadership. Depending on study scope and complexity, this role may coordinate activities of internal team members (e.g. Clinical Research Associates, Data Managers), and oversee multiple external vendors and consultants as needed. The Unblinded Clinical Trial Manager may also serve as the in-house Unblinded Lead Clinical Research Associate, as needed.
Position Responsibilities
Facilitate internal project team meetings as needed
Serve as the primary unblinded point of contact for sites, vendors and CROs, pharmacists and any unblinded study staff
Review temperature excursions; collaborate cross functionally to ensure timely resolution of site inventory non-conformances
Assist with investigational product (IP) site forecasting as needed
Conduct unblinded review of multiple study documents and deliverables across functions
Review CRO Unblinded Monitoring Visit Reports (uMVRs)
Conduct unblinded co-monitoring visits in accordance with the Sponsor Oversight Plan as needed
Track key performance indicators (KPIs) to assess CRO CRA and site performance, ensuring compliance with ICH-GCP, SOPs, Local Regulations, Protocol and Monitoring Plans
Manage interactions with investigators and site personnel to ensure compliance with regulatory expectations
Proactively identify, mitigate and escalate risks or issues impacting study timelines
Ensure the unblinded portion of the Trial Master File (TMF), maintained at the CRO, remains inspection-ready; rountinely review for compliance and oversee remediation of findings as needed
Oversee the Site Pharmacy setup activities as needed and serve as a liaison between Sponsor and site pharmacy teams as needed
Participate in vendor, site and CRO audits as appropriate
Plan and present at Investigator Meetings as needed
Adhere to departmental SOPs, GCP/ICH guidelines and applicable QC/QA procedures
May require travel, including international travel
Collaborate with Clinical Supply to assist in managing Interactive Response Technology (IRT)
Participate in User Acceptance Testing (UAT) as applicable
Participate in product recall activities, if needed
Assist with collaboration between study sites and Sponsor to resolve product complaints
Candidate Requirements
BS/BA degree in a scientific discipline; advanced degree preferred
Minimum of 3 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
Ability to adapt to change in a growth environment
Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
Understanding of the drug development process
Knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
Strong written and oral communication skills
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
