Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical 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 about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:
The Senior Clinical Trial Manager is responsible for all operational aspects of a clinical study from setup through final report, with support from Clinical Operations Leadership. Depending on the size of the study, the Clinical Trial Manager may coordinate the activities of several other clinical team members (e.g. Clinical Research Associates, Data Managers), as well as several external clinical vendors and/ or consultants. The Clinical Trial Manager may also assume the role of the in-house Lead Clinical Research Associate for a study, as needed.
Position Responsibilities
Implement clinical project plans in accordance with key study documents (e.g. protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
Facilitate internal project team meetings
Drive all aspects of study start-up, including CRO selection
Point of contact for sites, vendors and CROs
Monitor CRO and vendor adherence to scope of work
Manage interactions with investigators and investigative sites to ensure activities are conducted in accordance with all regulatory requirements
Proactively identify, resolve, and escalate issues that jeopardize timely clinical study completion
Develop and manage clinical trial budget and facilitate contract review
Participate in vendor, site and CRO audits as appropriate
Participate in site monitoring visits as necessary
Plan and present at Investigator Meetings, company, and other meetings as necessary
Develop internal tracking and reporting tools for reporting study status to Leadership
Adhere to all department SOPs, GCP/ICH guidelines, and QC/QA procedures
May require international and domestic travel (up to 20%)
Other duties and responsibilities as required
Candidate Requirements
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, 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.
