Wilmington, DE - Regional Monitor Lead

JOB DESCRIPTION:

• The Regional Monitor Lead provides regional monitoring expertise and oversight to Flexible Workforce Monitors and Internal Study Delivery Teams (SDTs)
• Regional Monitor Lead is responsible for the delivery of monitoring for assigned programs, ensuring workforce monitors are resourced and project trained to meet deliverables
• The Regional Monitor Lead establishes communications plans and field/site management while ensuring monitoring deliverables and milestones are met
• The Regional Monitor Lead collaborates with internal Study Delivery team, site staff and = field based employees (i.e. External Scientific Affairs)
• Regional Monitor Lead may also perform site visits to assess monitoring competencies and build site relationships

MAJOR RESPONSIBILITIES:

• Clinical Study Design, Execution and deployment of resources to given therapy teams
• Partners cross-functionally with internal Study Delivery Team members to develop timelines and milestones for clinical studies and communicate timelines to deployed Regional Monitors
• Assists internal Study Delivery Team in the recruitment and selection of investigators
• Participates in the development and communication of US patient recruitment strategy
• Plans and coordinates monitor training in conjunction with internal Study Delivery Teams
• Develops monitoring plan, ensuring compliance and documents deviations
• Facilitates the distribution of project instruction and monitoring tools to deployed Regional Monitors
• Reports and updates monitoring project deliverables (site selection, site enrollment, site compliance) to Study Delivery Lead and ensures implementation of corrective actions at sites as needed
• Identifies demand and manages deployment of flexible staffing resources to a given therapy/study team, maintaining adequate staffing to meet project needs.
• Oversees and trains flexible workforce Monitors’ on delivery of project assignments including site management, audit follow-up, and general project support
• Assists SDL/SDD in budget oversight related to monitoring
• Ad hoc review of workforce monitor expense reports, site allocations
• Ensures deployed regional monitors manage assigned sites understand and comply with the CSP, GCPs and SOPs
• Maintains positive and cooperative relationship in day-to-day interactions and communications with internal and external customers
• Ensures site monitoring visits schedule is adhered to and tracked, reviews site visit reports, site correspondence, telephone logs and other relevant documents to identify compliance issues and trends
• Ensures patient safety is maintained and informed consent procedures are properly executed
• Actively participates in pertinent project meetings, may present at Investigator Meetings, internal/external meetings and training sessions
• Oversees study information input into Clinical Trial Management System (IMPACT), ensuring study information is updated
• Proactively identifies study-related issues and provides timely resolution
• Contributes to process development and improvement by sharing best practices
• Provides monitoring expertise and technical information to SDTs
• Ensures appropriate communication with all necessary stakeholders and partners to ensure communication and field alignment
• Manages the deployment of workforce to given therapy teams
• Assist Study Delivery Team in the interim and final database lock activities
• Assist Study Delivery Team in the planning and oversight of adverse event database reconciliation
• Assist Study Delivery Team in the planning and oversight of site closeout activities including issue resolution

REQUIREMENTS:

• Demonstrates strategic influencing, analytical thinking, concern for standards, concern for impact, strong team skills including cooperation, willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity and conflict resolution skills
• Has in-depth knowledge of the clinical study process, GCP/ICH guidelines and SOPs
• Able to lead and facilitate regionally based flexible workforce, ensuring cross functional and in depth understanding of disease state/area and familiarity with latest research and industry best practices to the design and execute clinical studies
• Demonstrates sound project planning and execution skills
• Demonstrates advanced computer skills including troubleshooting
• Excellent organization and time management skills; detail-oriented; ability to multi-task in a high volume environment
• Demonstrates ability to prepare and present at internal and external meetings
• Demonstrates Leadership, professionalism, diplomacy, mutual respect and embraces diversity
• Demonstrates customer relationship building and management skills
• Establishes professional relationships and networks with academia and national thought Leaders
• Bachelor degree in biological science or health-care related field
• Minimum of 4 years direct regional monitoring experience
• SCRA or direct management experience, 6-8 years of relevant experience in industry with excellent performance
• Advanced knowledge of the clinical study process, GCP/ICH guidelines
• Practical knowledge of study management (i.e. IMPACT)
• Experience in e-Clinical applications
• Proficiency in MS Office Tools
• Effective decision-making, ability to identify and understand issues, problems and opportunities
• Excellent planning and organizational skills; ability to establish course of action for self and others to ensure deliverables are met
• Ability to travel – Valid Driver’s License
• Strong interpersonal and presentation skills
• Excellent oral and written communication skills
• Detail-oriented
• Demonstrated effectiveness working independently, collaboratively with peers cross-functional teams, site personnel and field colleagues
• Actively participates and contributes to team success

PREFERED BACKGROUND:

• Demonstrated ability to successfully manage clinical studies to time and quality metrics
• Demonstrated ability to lead a team
• Internal and External Contacts/Customers
• Clinical Investigators
• Study Site Personnel
• Study-specific advisory and/or steering committees
• SD personnel
• USDD personnel
•  External service providers
• Universities, Academia and Thought Leads
• Monitoring Vendor

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