Reshma Soodana

• Supervised day-to-day operations to meet performance, quality and service expectations.
• Offered hands-on assistance to customers, assessing needs, and maintaining current knowledge of consumer preferences.
• Conducted performance evaluations and provided constructive feedback to employees.
• Manages the set up and maintenance of electronic Trial Master Files (eTMF), Trial, Country,
  and Site artifacts for clinical studies in support of sponsors services contracts and internal
  Fortrea business needs. Oversees and leads moderately complex studies to support the BP&SeTMF team and overall CDS group.
  • Assumes responsibility as client workstream lead specialist. Manages, mentors and trains
  junior staff members
• Quality Management Oversight: Responsible for overseeing the overall quality and compliance of the eTMF system, ensuring audit readiness and compliance with regulatory guidelines (GCP, ICH, etc.).
• eTMF Setup and Maintenance: Manages the setup, maintenance, and continuous improvement of the electronic Trial Master File (eTMF), working with project teams and sponsors.
• Document Quality Checks: Leads visual quality checks and audit-readiness reviews of e-documents, ensuring image clarity, completeness, and accuracy of TMF artifacts.
• Process Improvement and Compliance: Implements business improvement initiatives, identifies trends in TMF quality issues, and ensures client satisfaction through proactive monitoring and resolution of TMF-related issues.
• Audit and Inspection Preparation: Prepares the eTMF for audits and regulatory inspections, collaborating with teams and clients to ensure compliance and resolve audit findings.
• Team Management and Development: Leads a team of eTMF specialists, managing performance, coaching, and mentoring, while ensuring effective onboarding and development of new team members.

• Payment Processing and Tracking: Administers payments to investigators and other payees, ensuring accurate tracking and processing of all pass-through costs and study-related payments.
• Budget Assistance: Supports the preparation of study budgets and collaborates with GSS Site Contracts teams to define payment terms in investigator agreements.
• Communication and Customer Service: Liaises with clinical teams and sites regarding payment updates and queries, ensuring timely issue resolution and maintaining strong communication.
• Financial Reporting and Reconciliation: Reconciles study payments regularly, provides financial reports to clients, and supports sponsor audits with necessary payment documentation.
• Team Support and Mentoring: Mentors team members, assists with workload distribution, and conducts training for new team members, ensuring smooth team operations.
• Process Improvement and System Development: Contributes to process improvements and the development/testing of new Grant Payment systems, while identifying opportunities to streamline operations.

• Manage clinical systems, study documents, databases, and communications.
• Support studies, handle payments, and ensure compliance with procedures.
• Execute tasks efficiently and drive process improvement.
• Provide comprehensive support for study teams and maintain high-quality standards.

• Provide Centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas
• Perform assigned complex administrative tasks to support CPM and other team members with project execution
• Establish and maintain effective project/site communication( I CRA Tasks)
• Create and maintain relevant project documentation Ensure accurate completion and maintenance of internal systems, databases, tracking tool and project plans with project specific information.

Participate in team meetings and implement activities

• Assist Team in preparing Template I-site packs