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 leading global clinical trials for Disc Medicine. Focused on project management and vendor oversight within a hybrid work environment.
Responsibilities
- Covers end-to-end study support from planning through closeout:
- Support overall management of global clinical trials (planning, execution, closeout)
- Monitor study progress, budgets, and timelines
- Assist with planning and conduct of investigator meetings
- Perform periodic visits to sites/CROs to assess study progress and protocol compliance
- Review monitoring visit reports and ensure timely resolution of action items
- Liaise with clinical sites and Investigators to maintain effective Sponsor-site relationships
- Ensures compliant, high-quality trial delivery:
- Assist in evaluation, selection, and oversight of CROs, vendors, and consultants
- Review and approve vendor-generated operational plans
- Ensure audit readiness of trial documentation (including TMF)
- Ensure compliance with GCP and regulatory requirements
- Proactively identify, manage, and mitigate study risks
- Supports regulatory documentation and business operations:
- Participate in SOP preparation and review
- Contribute to drafting and reviewing clinical documents (protocols, ICFs, IBs, reports, ASRs/DSURs, status updates)
- Support meeting coordination, agendas, minutes, and metric tracking
- Perform additional responsibilities as assigned by the line manage.
Requirements
- BA/BS required
- Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
- Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
- 7+ years of applicable clinical trial experience (5 years of vendor and CRO management) required
- Thorough knowledge of FDA, EMA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
- Must be willing to travel both domestic and internationally
- Experience in orphan indications will be favorably considered
- Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
- Experience working on project teams is required
- Candidate should be a self-driven individual with skills in organization, building working relationships and communication.
- Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., data management, biostatistics, regulatory, pharmacovigilance, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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