Clinical Trials Project Leader

2 weeks ago

Columbia, South Carolina, United States Thermo Fisher Scientific Full time

We are looking for experienced professionals to oversee comprehensive Ophthalmology clinical trials.

Senior Project Manager/Lead (Delivery)

At Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Collaborate with our team to realize our Mission - empowering our clients to enhance global health, safety, and cleanliness. We equip our teams with the necessary resources to reach personal career aspirations while advancing scientific endeavors through the research, development, and delivery of transformative therapies. With clinical trials conducted in over 100 countries and the continuous evolution of innovative frameworks for clinical research through our PPD clinical research portfolio, our efforts encompass laboratory, digital, and decentralized clinical trial services. Your commitment to ensuring quality and precision will enhance health outcomes that communities rely on now and in the future.

Our Project Delivery team within our PPD clinical research services is responsible for directing, coordinating, and managing the technical and operational elements of projects, ensuring the successful execution of clinical trials. This involves collaborating with functional area leaders to identify and assess critical issues within the project and ensuring effective solutions are put in place. Project Delivery is essential in assisting our clients in delivering transformative therapies.

Through our global team, you may participate in various initiatives and projects or be part of a virtual international project team, gaining valuable cross-cultural experience.

Discover Meaningful Work:

We are in search of a Senior Project Manager/Lead for our Ophthalmology Team. This position will be filled at the Project Manager/Senior Project Manager level based on experience. This role is designated for the North America region and is remote-based.

The Project Lead is responsible for the overall delivery of the project (quality, time, cost) on behalf of the organization. They establish and communicate client expectations to the project team with minimal oversight. They ensure adherence to escalation pathways both internally and externally. The Project Lead guides the cross-functional project team to meet or exceed project deliverables. They manage projects of increasing complexity, including multi-service, multi-region/country, therapeutic complexity, and financial scope.

A Day in the Life:

Acts as the primary liaison and leader between the sponsor and the organization at the project level. For projects with complex scopes, ensures clear delineation of responsibilities and communication pathways for secondary project leads. Drives and owns the overall delivery of the cross-functional project (time, cost, quality). Ensures financial stewardship at the project level by demonstrating a thorough understanding of the contract, aligning resources to budget, managing out-of-scope activities, and overseeing the contract modification process. Establishes, communicates, and manages client expectations to achieve optimal project delivery. Facilitates risk identification and issue resolution at the project level. Ensures project team compliance with organizational 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

Prior experience that provides the knowledge, skills, and abilities to perform the job (typically 8+ years). 5+ years of management experience. Proven leadership capabilities.

Years of experience refer to the typical duration of related experience needed to acquire the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience should not be the sole determining factor in establishing job classification or making employment selection decisions.

Knowledge, Skills, Abilities

Comprehensive knowledge of therapeutic areas, clinical development guidelines, and regulatory standards. Expert understanding of key principles of cross-functional project management (Time, Quality, Cost). Exceptional 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 proficiency, including effective use of systems and applications such as Microsoft Outlook, Word, Excel, and PowerPoint, as well as organizational systems. Proven adaptability and ability to prioritize workload and resources for project team members in a dynamic environment. Skilled in process improvement and strategic development, particularly in relation to clinical trials and project management. Ability to coach, mentor, and lead global and/or cross-functional teams with cultural awareness. Strong financial acumen with in-depth knowledge and practical application of budgeting, forecasting, and resource management. Excellent customer service, consultation, and relationship-building skills. Advanced negotiation and marketing skills with the ability to influence others and drive results. Exceptional judgment, decision-making, and problem-solving skills, with proven ability to apply critical and analytical strategic thinking to manage complex situations. Proactive, solutions-oriented, and skilled in risk identification and management.

Work Environment

Thermo Fisher Scientific prioritizes the health and wellbeing of our employees. We encourage individuals to cultivate a healthy and balanced environment where they can thrive. Below are the working environment/requirements for this role:

Ability to communicate, receive, and understand information and ideas with diverse groups of people in a clear and reasonable manner. Ability to work upright and stationary for typical working hours. Proficiency in using and learning standard office equipment and technology. Capability to perform successfully under pressure while managing multiple projects or activities. Travel may be required.

Our Mission is to empower our clients to enhance global health, safety, and cleanliness. As one team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working collaboratively to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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