Remote Project Director

Summary

Join a team passionate about precision medicine and advancing the healthcare industry. As a Program Manager, Global Project Lead or Project Manager, you will lead cross-functional teams and manage projects from start-up to close-out, ensuring delivery within specified budgets and timelines.

Requirements

• University/college degree with preference in a health or life science field from an appropriately accredited institution
• Minimum of eight (8)+ years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
• Minimum of six (6)+ years Project Management experience at a CRO
• Oncology clinical trials
• Early phase oncology clinical trial experience
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
• Demonstrated ability to build rapport with team members and clients
• Excellent written and verbal communication skills
• Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines
• Able to proactively anticipate needs and follow through on all assigned tasks
• Proficient in MS Office, specifically Microsoft Word,Excel, and PowerPoint
• Proficient in Project Management Tools utilized for planning/scheduling, collaboration and evaluation
• Ability to travel overnight (up to 20%)

Responsibilities

• Manage the assigned project(s) scope of work and associated contractual agreements including recognizing and negotiating changes in scope
• Act as primary point of contact for clients and collaborate with them to proactively provide win/win solutions
• Manage the assigned project(s) throughout the project lifecycle from start-up to close-out
• Lead cross-functional teams and third parties/vendors to ensure effective teamwork and communication
• Manage and analyze project deliverables including timeline, quality, scope, and financials
• Develop project-specific plan(s) as required, including the Project Management Plan
• In conjunction with functional area leads and client, recommend, implement and oversee operational strategies as well as risk management plans inclusive of the Risk Assessment Categorization Tool (RACT)
• Lead project meetings including creation and maintenance of agendas, actions, decisions and issues
• Ensure inspection ready Trial Master File (TMF) for the duration of project(s); perform maintenance tasks such as filing; lead periodic quality reviews; prepare for audits and project archiving
• Maintain and update project-related systems such as the project specific SharePoint site(s) and/or other tracking mechanisms as applicable
• Maintain project specific training matrix and ensure the administration of project related training materials via the Tempus Compass Learning Management System (LMS)
• Identify and manage resource needs throughout the project lifecycle including ensuring that project tasks are correctly assigned to team members and vendors
• Oversee and coordinate Project Manager(s) working on assigned project(s), including regional CRO Partners, as required
• Manage team dynamics and provide feedback on project team members’ performance to the project team member and respective supervisors
• Contribute to business development initiatives, including proposals, responses to RFIs, and bid defense presentations
• Contribute to project management initiatives
• Serves in a mentorship role to project management staff with minimal supervision and guidance

Preferred Qualifications

• PMP (Project Management Professional) Certified
• Cell Therapy experience
• Global Project Management experience