Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Clinical Trial Manager overseeing operational aspects of clinical studies at Scholar Rock. Implementing project plans and coordinating team activities throughout the study lifecycle.
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
- Ensure trial master file (TMF/eTMF) is established, current, and maintained.
- 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
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
Benefits
- Health insurance
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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