Meg Carini

• Proactively develops outsourcing specifications for vendor requests for proposals and leads study team in vendor identification, selection and management.
• Responsible for providing oversight in the development of operational plans, prioritizes tasks within the plans to achieve project goals, while ensuring quality and compliance to Protocol, SOPs, Federal and international regulations and GCP.
• Contributes expertise to the writing and or review of clinical documents such as Protocols, informed consents, and Investigator Brochures, study plans.
• Builds stakeholder commitment to deliverables and ensures progress toward the completion of one or more clinical trial(s) in line with agreed study objectives.
• Regularly meets with the Vice President of Clinical Operations and Senior Vedanta Leadership, as applicable, to discuss overall clinical trial(s) plans, updates, forecasting and potential issues and provides solutions.
• Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
• Responsible for effective communication within the project team and with functional management regarding trial status.
• Coordinates and provides oversight of all elements of the project lifecycle from initial set-up to close out.
• Manages cross-functional teams including clinical research associates, data managers, and regulatory specialists to ensure smooth trial execution.
• Manages vendor to Scope of Work (SOW), quality, and budget. Reviews and approves all vendor invoices and proactively recognizes any changes in SOW and collaborates with CRO to manage accruals and SOW changes.
• Works with CRO and/or core team members to address issues and risks associated with achieving the deliverables. Develops risk mitigation plans and presents to Senior Management.
• Reviews, completes and assures implementation of corrective action plans in conjunction with Senior Management at individual sites and across the study as applicable. May participate in internal/external study related audits/inspections and act as coach and mentor.
• Develops and maintains relationships with key opinion leaders (KOLs) and investigative sites.
• Responsible for ensuring the study(ies) is/are always 'audit ready' (e.g. project team training records, trial master file).
• Attends and contributes to Product Development meetings and reports on progress of assigned studies.
• Demonstrates thorough knowledge of and coaches' others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
• Provides leadership and mentorship to clinical operations staff, fostering a culture of accountability and continuous improvement.

Executed successful implementation of Agenus, Collaborative, Investigator-Sponsored, and expanded access programs.

Managed international programs within established budgets and timelines.

Demonstrated excellence in complex project management across multiple priorities.

Initiated continuous reviews to identify best practices and enforce standardization among study teams.

Applied critical and creative thinking to independently determine necessary resources for resolving complex issues.

Resolved intricate problems using advanced independent judgment regarding national and international regulations.

Directed development of SOPs within department and contributed to collaborative SOP creation.

• Successfully managed global clinical program to BLA submission to meet corporate goals.

Executed projects within budget and regulatory guidelines as Project Manager.

Mentored Lead CRAs and junior CRAs to strengthen team performance.

Oversaw first international study in partnership with six CRO vendors.

Managed multi-million dollar study budget, ensuring effective CRO administration.

Directed project team operations, coordinating internal functional groups and regional monitors.

Identified resource needs for projects and ensured timely completion of monitoring reports.

• Used excellent verbal skills to engage customers in conversation and effectively determine needs and requirements.

• Managed medication administration and monitored patient responses effectively.
• Collaborated with interdisciplinary teams to enhance overall patient treatment strategies.
• Ensured adherence to infection control standards throughout the rehabilitation facility.

• Managed medication administration and monitored patient responses effectively.
• Evaluated patient conditions regularly to adjust care plans as necessary.
• Coordinated and performed patient admissions, transfers and discharges.