Senior Clinical Project Manager

About Thermo Fisher Scientific

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.

Our Project Delivery colleagues within our PPD® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. This includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. Project Delivery is vital to helping our customers deliver life-changing therapies.

Through our global team, you may engage in diverse initiatives and projects, or be part of a virtual international project team gaining cross-cultural experience. Therapeutic scopes include: infectious and respiratory diseases, oncology/hematology, neurosciences, cardiovascular and metabolic, general medicine and vaccines.

Discover Impactful Work as a Senior Clinical Project Manager

We are always looking for talented individuals who are passionate about what they do and eager to grow with us! Our Talent Pool requisition seeks Clinical Project Leaders who has worked in: Dermatology, Cardiology, General Medicine, Nephrology & NASH, Hematology & Oncology, Vaccines, Infectious, Respiratory & Critical Care Diseases, and Neuroscience.

The Senior Clinical Project Manager is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project(s) of increasing complexity (such as but not limited to: multi-service, multi-region/country, therapeutic complexity, financial scope).

A Day in the Life

• 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.
• 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.

Keys to Success

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• 5+ years of management responsibility.
• Proven leadership skills.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities

• 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.

Key Skills/Competency

• Clinical Project Management
• Cross-functional Leadership
• Regulatory Compliance
• Financial Stewardship
• Risk Management
• Clinical Trials
• Therapeutic Area Expertise
• ICH-GCP
• Issue Resolution
• Stakeholder Communication