Manager, Portfolio Operations, Medical Evidence Generation

Job Summary

The Manager, Portfolio Operations provides centralized operational support, systems oversight, compliance execution, and administrative services across the MEG Operations team and portfolio, allowing Global Trial Leads (GTLs) and Global Trial Associates (GTAs) to focus on study leadership and end-to-end study accountability and execution. This role serves as the central point of accountability for systems, documentation, quality and compliance (e.g., eTMF, CTMS, financial administration, purchase order management, invoice processing, and study documentation oversight).

This role works closely with therapeutic area (TA) MEG Operations team to drive standardization, compliance, and operational efficiency across the portfolio. This is a centralized, cross-therapeutic-area role supporting all medical studies within MEG Operations.

This role will report into the Senior Director, Business Operations Lead, MEG Operations.

Responsibilities

• Owns portfolio-wide eTMF oversight, quality, completeness, and inspection readiness.
• Drives periodic eTMF health reviews and remediation activities.
• Establishes standards, metrics, and KPIs for document compliance.
• Ensures consistent document management practices across all studies.
• Manages CTMS processes and data quality.
• Monitors study records, milestone accuracy, and portfolio reporting.
• Implements governance for system usage and compliance.
• Supports system enhancements, training, issue resolution.
• Manages centralized invoice processing and reconciliation activities.
• Oversees purchase order creation, tracking, and lifecycle management.
• Ensures compliance with procurement and financial controls.
• Supports budget tracking and accrual monitoring.
• Follows standardized closure and archival processes.
• Coordinates documentation readiness for closed studies.
• Monitors closure milestones and archive compliance.
• Partners with GTLs/GTAs to support timely study closeout.
• Creates and maintains standardized tools, templates, checklists, and workflows.
• Harmonizes operational practices across therapeutic areas.
• Identifies efficiency opportunities and automation solutions.
• Establishes consistent service delivery models across the portfolio.
• Monitors operational compliance metrics across studies.
• Coordinates remediation activities for recurring operational issues.

Qualifications

• BA/BS or equivalent degree in relevant discipline.
• Manager level: minimum 3-5 years of experience in clinical/medical trial operations, systems administration (eTMF/CTMS), financial operations, or related pharmaceutical/healthcare industry experience.
• Experience with eTMF and CTMS systems required.
• Experience with purchase order management, invoice processing, or financial administration in a clinical/medical trials environment preferred.
• Strong understanding of GCP/ICH guidelines, document management standards, and inspection readiness requirements.
• Excellent organizational skills with strong attention to detail.
• Ability to manage multiple studies and therapeutic areas simultaneously and prioritize competing demands.
• Strong communication and stakeholder management skills, with the ability to partner effectively with cross-functional partners.
• Experience driving process standardization or continuous improvement initiatives preferred.
• Travel requirement of up to 5%.