(Sr) Project Manager - Respiratory Diseases Team - Remote based in the US

Thermo Fisher Scientific is seeking a (Sr) Project Manager to lead and deliver complex respiratory diseases clinical trials on a remote basis in the US. The role involves overseeing project delivery, ensuring compliance with regulatory standards, and managing cross-functional teams.

Responsibilities:

• Overseeing project delivery, ensuring compliance with regulatory standards, managing cross-functional teams, and acting as the main contact for sponsors
• Serves as the primary contact and lead between the sponsor and the organization at the project level
• On projects where the scope requires, ensures 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)
• Drives and owns the overall delivery of the cross-functional project (time, cost, quality)
• Ensures 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
• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project
• Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE)
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements

Requirements:

• Minimum of 8 years' experience in clinical trials
• At least 5 years in management
• Bachelor's degree or equivalent
• Strong leadership and communication skills
• Proficiency with project management systems and tools
• Legal authorization to work in the US
• Ability to pass a background check
• Advanced financial acumen
• Strategic thinking
• Ability to manage multiple projects in a dynamic environment
• Demonstrated experience running full service clinical trials with a specialty in Respiratory Diseases
• Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines
• Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost)
• Excellent oral and written communication and presentation skills
• Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity)
• Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment
• Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management
• Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness
• Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
• Excellent customer service, consultation and relationship building skills
• Advanced negotiation and marketing skills with ability to influence others and drive results
• Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations
• Proactive, solutions oriented and skilled at risk identification and management
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
• Able to work upright and stationary for typical working hours
• Ability to use and learn standard office equipment and technology with proficiency
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
• May require travel