Scholar Rock is discovering and developing a pipeline of innovative new medicines to treat a range of serious diseases with high unmet medical need, including neuromuscular diseases, cancer and fibrosis.
By focusing on the newly elucidated biology of growth factor activation, Scholar Rock has developed new insights which allow us to selectively target growth factors in the disease microenvironment, to achieve therapeutic effects specifically at the source of disease. Our proprietary technology enables the development of innovative medicines that modulate the supracellular activation of growth factors in order to unlock the vast therapeutic potential of targeting growth factors to treat disease, and deliver new solutions for patients. Our most advanced product candidate, SRK-015, is being developed for the treatment of patients with Spinal Muscular Atrophy (SMA).
Scholar Rock is led by a highly-experienced management team of leaders who have built successful biotechnology companies, and is backed by leading investors.
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.
- 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
- 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
- Manage study drug labeling, release, reconciliation and supply management activities
- 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 travel, including international travel
- Other duties and responsibilities as required
- 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
- 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.