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Open Positions
Review, draft, negotiate and track a variety of legal agreements. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. Serve as a subject matter expert within the department and company regarding site contract management.
Contracts
Negotiation
CRO
Work closely with stakeholders to deliver Site Contracts in the shortest possible time and align with study timelines. Support contract negotiations and deal with key clients; participate in strategic initiatives. Manage a team of contract and budget associates, allocate resources, and report on contract metrics.
Contracts
Negotiation
Management
Leadership
MS Office
Review, draft, negotiate and track a variety of legal agreements. Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines. Ensure adherence to company policies, procedures and contracting standards.
Drafting
Negotiation
Contract Law
Communication
MS Office
Management and operational delivery of clinical elements within a trial. Successful execution of assigned trials and ensuring completion of deliverables. Identify challenges to study timelines and offer creative action plans.
MS Office
MS Project
PowerPoint
CTMS
ETMF
Monitor and own the progress of clinical studies at investigative sites. Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Communication
Organizational Skills
Monitoring
Site Management
Clinical Research
Lead, mentor, coach, and manage Clinical Trial Managers to support skill development and career growth. Partner with Clinical Operations leadership and cross-functional teams to improve processes and quality. Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.
Clinical Research
ICH GCP
Communication
Interpersonal
Management
Ensure the development and implementation of action plans. Lead regional/therapeutic area project resourcing. Develop, mentor, manage and coach GCM Managers.
ICH-GCP
Clinical Operations
Data Management
Clinical Research
Lead governance initiatives across SharePoint Online, Microsoft Teams, OneDrive, and Power Platform. Design and maintain least-privilege permission models across M365 workloads. Define and operate lifecycle management for M365 resources, including archiving inactive Teams, Sites, and Groups
Microsoft 365
PowerShell
Power Automate