Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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 - enabling 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Manages and leads projects to deliver the intended business benefits according to timelines, budget and quality standards.
• Directs activities of global cross-functional teams and works with organization to ensure project dependencies are identified and communicated.
• Creates program timelines as well as detailed project plans; assesses Work Breakdown Structure (WBS), resource loading, dependencies, and milestones.
• Plans and manages budgets associated with technology projects.
• Evaluates percentage complete, tracks actuals to budget and mitigates overspend, tunes resource model to adhere to budget guidelines.
• Collaborates with the business teams on ROI measurements and benefits realization compared to baselines.
• Ensures risks/issues are surfaced and mitigated, escalating information and recommending issue resolution as appropriate.
• Ensures project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements.
• Supervises external vendors.
• Maintain Business Process Owner/Subject Matter Expert lists.
• Coordinate document workflows from submission through approval.
• Assist in tracking Change Requests: Facilitate change requests with Business Process Leads (BPOs) and support the process of obtaining approvals from leadership.
• Coordination and Support: Coordinate process team meetings and manage the distribution list and PTDS mailbox.
• Documentation and Maintenance: Assess changes for training updates and post-process all changes to determine necessary updates.

• BS, MS or equivalent in scientific field
• Minimum of 5+ years' experience in pharmaceutical, CRO, healthcare or related industry
• Minimum of 2+ years' experience with QMS and process development for clinical trial delivery
• Solid understanding of US CFR, GCP, ICH regulations and the clinical development process
• Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
• Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and project teams to turn vision into reality.
• Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects
• • Extensive experience in design or in implementing solutions and preferable experience in quality improvement.
• Excellent oral and written communication skills, business acumen, and enterprise knowledge.
• Work with virtual/agile teams in different locations, aligning and adapting different work, culture, and communication styles.
• Effectively communicate complex problems and proposed solutions across various levels of the organization
• Function well under pressure in a changing environment

• Proficiency in the key principles of cross-functional project management (ex: time, quality, cost)
• Experience with Lean Six Sigma, Agile and Scrum methodologies
• Familiar with formal change management processes and methods (Prosci or similar approach)
• Strong financial acumen
• Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels
• Critical thinker with solid judgment and strong initiative
• Demonstrated ability to lead and influence collaboration across multiple and diverse groups
• Strong leadership and teamwork abilities
• Ability to work independently and be a creative and innovative problem solver
• Ability to delegate, effectively prioritize own and project team members workload
• Ability to effectively use automated systems and computerized applications such as Microsoft Project, PowerPoint, Outlook, Excel, Word, etc. and Visio
• Strong verbal and written communication, time management, and organizational skills