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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementvendor managementCRO managementregulatory complianceGCP guidelinesSOP preparationclinical document draftingproject managementrisk managementdata management

Soft Skills

self-motivatedproactiveorganizational skillsinterpersonal skillscommunication skillsrelationship buildingprioritizationteam collaborationbusiness acumenmultitasking