Overview

Responsible for the management of strategic projects/programs related to clinical and corporate operations. In concert with leadership, the Program Manager is accountable for achieving successful delivery of Curevo Vaccine's clinical team activities at the project level by meeting organizational and regulatory requirements according to time, quality/scope and budget constraints. Provide support for CMC framework, project management of multiple project work-streams, assist with the development and management of PM materials for work-streams and support coordination and management of external service providers and other outsourcing needs for current and future clinical trials.

Responsibilities

• Oversee lean, agile and efficient operational aspects to fulfill the mission of accelerating the path to developing new vaccine candidates.
• Responsible for the management of strategic projects/programs including budgets, contracts and timelines.
• Clinical sample management including oversight and coordination of biological samples and data
• Oversight of Bioanalytical lab projects and task coordination.
• Provide support and expertise in developing effective clinical contractual agreements, budgets and proposals.
• Effectively communicate, develop and cultivate operationally excellent internal cross-departmental and external service provider relationships to enable advancement of clinical development programs.
• Negotiate change orders and ensure service providers adhere to contract terms. Review invoices against vendor contracts to ensure accuracy and service completion.
• Generate Request for Information (RFIs), Request for Proposal (RFPs) and budget grids/trackers for clinical trials and assist Clinical Operations Management with the service provider selection process including bid comparison analysis.
• Coordinate bid defenses and proposal review meetings.
• Assist Clinical Operations Management with creating clinical trial budgeting models.
• Assist management with audits of contract and sourcing records to ensure accuracy and completeness.
• Assist in the development, improvement and implementation of processes and tools related to outsourcing activities including a database for identifying and maintaining current and potential service providers.
• Manage the contract negotiation process with the support of Curevo legal counsel resources.
• Support the day-to-day activities of multiple areas in complex processes.
• Support and manage general and departmental ad hoc projects as required.

Job Requirements

• Review and approve all operational invoices, cross-check against agreements, obtain approval, and ensure they are submitted for payment in a timely manner.
• Communicate all operating policies and/or issues at department meetings.
• Triage regulatory compliance functions for R&D and clinical.
• Create and maintain operational and financial metrics dashboards and reports that accurately measure performance.
• Establish communication channels for sharing continuous improvement initiatives within Curevo's operational network and ensure alignment between collaborators, partners and sites.
• Work and communicate effectively and professionally in a cross-functional team environment with minimal supervision.
• Other duties as assigned by Director, Program Management.