At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
The Project Manager (Non-Interventional Studies) serves as the Project Lead and primary sponsor contact. Accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates client expectations to the project team. Ensures that critical issue pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed client deliverables.
- 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).
- 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 expectations to achieve efficient delivery during the project
- Drives Risk Identification and Issue Resolution at project level
- Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.
Education and Experience:
- Bachelor's degree and / or equivalent, preferably in biological sciences or healthcare-related disciplines
- Real World Evidence and Late Phase experience is required including but not limited to observational studies, post-authorization safety surveillance, patient reported outcomes and registries
- Experience in working on a wide range of therapeutic indications
- At least 2 years project management experience within clinical research and study operations
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’)
- Regional experience
Knowledge, Skills and Abilities:
- Extensive knowledge of operational aspect of observational studies, clinical trials, end to end delivery of project.
- Excellent technical and systems proficiency, 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)
- 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
- Strong understanding of the key principles of project management (time, quality, cost), including solid financial competence
- Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
- Critical thinking and problem-solving skills to lead complex/ambiguous situations
- Ability to persuade and influence others, including a cross cultural awareness
