Project Manager - Phase I, Early Development

About the role

The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of Trialmed. The role involves leading the cross-functional project team to meet or exceed deliverables, establishing and communicating customer expectations, and ensuring escalation pathways are adhered to internally and externally.

Responsibilities

• Serve as the primary contact between the sponsor and the organization at the project level.
• Ensure escalation pathways are adhered to internally and externally (Rules of Engagement – communication pathways).
• On projects where the scope requires, ensure clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
• Accountable for the overall delivery of the cross-functional project (time, cost, quality).
• Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations, and team execution to timelines.
• Establish, communicate, and manage customer expectations to achieve optimal delivery during the project.
• Drive Risk Identification and Issue Resolution at the project level (RBQM/RESOLVE).
• Ensure project team compliance with organization policies, SOPs, ICH-GCP, regulatory, and project-specific requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Skills

• Technical and systems competency, including effective use of Microsoft Outlook, Word, Excel, PowerPoint, and organization systems (CTMS, Preclarus, Clarity).
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment.
• Effective oral and written communication and presentation skills.
• Proactive, solutions-oriented, and adaptable to changing priorities and situations.
• Advanced therapeutic area knowledge and clinical development guidelines and directives.
• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen.
• Sound interpersonal and customer service skills, including the ability to lead, motivate, and coordinate cross-functional project teams.
• Good judgment and decision-making skills, capable of applying critical and analytical strategic thinking to manage complex/ambiguous situations.
• Ability to negotiate, persuade, and influence others, including cross-cultural awareness.

Environmental Conditions

• Work is performed in an office, laboratory, and/or clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required, such as protective eyewear, garments, and gloves.