Senior Clinical Trial Manager
Remote
Development – Clinical Operations /
Full-Time /
Remote
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock 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. The person in this role may supervise other clinical personnel, internal and/or external consultants and service providers.
Position Responsibilities:
- Implementation of eTMF vendor (Veeva) and development of eTMF SOPs
- Review of eTMF documents both internal and at study CRO
- 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
- Experience with eTMF implementation and management of eTMF vendor
- Understanding of inspection readiness task and participation in inspection activities
- 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.
