Scholarrock2mo ago

Unblinded Clinical Trial Manager

United States·CambridgeFull-Timemid

HealthcareClinical Researcher

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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:

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

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.